Tuesday, June 30, 2020

ISO 13485:2016 COMPLAINT HANDLING PROCEDURE

Hi friends!!!

Today we are going to discuss about complaint handling procedure specified in ISO 13485:2016.

CLAUSE 5.6.2 suggest complaints to be one of the mandatory inputs in management review.

CLAUSE 8.2.2 gives procedural requirements of complaint handling.

ISO involves complaints in risk management.


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Therefore, it is important for every medical device regulatory professional to know in detail about complaint handling procedure.

Let’s get into the topic.

ELEMENTS OF COMPLAINT HANDLING PROCEDURE

The complaint handling procedure has 10 steps as following.

APPLICABLE TO REGULATORY REQUIREMENTS

The customer complaint handling procedure should be compliant with applicable regulatory requirements.

RECEIVING AND RECORDING INFORMATION

Receiving and recording information procedure should address how all received complaints are routed within organization, recorded and saved in complaint log or complaint management system (in the scope of enterprise resource planning ERP system).

COMPLAINT EVALUATION

The complaints handling procedure should check whether the complaint is valid or not. If not, no further proceedings are made. Justification records are maintained for non-valid complaints.

REPORT TO REGULATORY AUTHORITY

1. Important aspect of complaint handling procedure is that serious complaints having adverse impact on patient’s health must be routed to regulatory authorities.

2. Authority can stop the sales of that product for a period of investigation and corrective action.

3. In some cases, a particular device should have to be recalled from the market.

4. Complaints has to be resolved and closed by regulatory authorities.

5. All records of reporting to regulatory authority have to be maintained by company itself.

COMPLAINT INVESTIGATION

Identification of root cause, so that subsequent actions can be identified.

HANDLING OF COMPLAINT ABOUT RELATED PRODUCT

In complaints handling all returned products by customers are properly tagged and identified. All returns are reworked and shipped again or these returns are discarded and replacements issued to the customers. The customer complaint handling procedure should address all these queries so as to minimize the risk of returned product being mixed with inventory of production.

CORRECTION AND CORRECTIVE ACTION

1. Take actions to address the root cause.

2. May be rework or offer replacement.

3. Records for corrections and corrective actions must be maintained.

THIRD PARTY INVOLVEMENT

1. Sometimes complaint is a result of third-party services in manufacturing or delivery of medical device. Example: Shipping services.

2. The complaint handling procedure should address the mode of communication with external service providers.

3. The investigation findings that highlight their contribution or any corrective action on their part must be shared with proper documented records.

REVIEW OF SERVICING RECORDS

1. Servicing records are details of activities taken under scheduled or breakdown maintenance.

2. If records identify the issue of complaint, the whole complaint handling procedure has to be initiated.

 

Now I hope you have acquired some knowledge about complaint handling procedure of ISO 13485:2016. We will see a different topic related to healthcare in our next blog.

NOTE: Dear friends!!! ...Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


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Sunday, June 28, 2020

ISO 13485:2016 MEASUREMENT, ANALYSIS AND IMPROVEMENT - PART 2

Hi friends!!!

In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6, CLAUSE 7, CLAUSE 8. Please check out for the links given below.

CLAUSE 4

CLAUSE 5

CLAUSE 6

CLAUSE 7 - PART 1

CLAUSE 7 - PART 2

CLAUSE 8 - PART 1

Today we are going to see about CLAUSE 8.3, 8.4 and 8.5 of ISO 13485;2016. 

Let’s get into the topic with a small introduction about ISO 13485;2016.

WHY ISO 

13485:2016?

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements. Such organisations can be involved in Design & Development of Medical Device, Production, Storage  and Distribution, Installation and Servicing of Medical Device or provision for other associated activities (eg: Technical Support).


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CLAUSE 8 MEASUREMENT, ANALYSIS 

AND IMPROVEMENT

It is divided into following sub clauses.

CLAUSE 8.1 General

CLAUSE 8.2 Monitoring and measurement

CLAUSE 8.3 Control of non-conforming product

CLAUSE 8.4 Analysis of data

CLAUSE 8.5 Improvement


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In our previous blog CLAUSE 8 - PART 1 we have discussed about clause 8.1 and 8.2. Now we are going to see clause 8.3, 8.4, 8.5.

CLAUSE 8.3 Control of non-conforming product

It is divided into following sub clauses.

Clause 8.3.1 General

1. Discuss the prevention of unintended delivery or use of non-conforming products.

2. Explain how you intend to prevent unintended product delivery or use.

3. Avoid the unintended delivery or use of your non-conforming products.

4. Keep record of your organizations non-conforming products activities.

CLAUSE 8.3.2 Actions in response to non-conforming product detected before delivery

1. Deal with non-conforming products before delivery.

2. Take actions to eliminate detected non-conformities.

3. Prevent products original intended use or application.

4. Authorize non-conforming products use, release or acceptance.

CLAUSE 8.3.3 Actions in response to non-conforming product detected after delivery

1. Recognize non-conforming products after delivery or after use.

2. Act as appropriate to counter the effects that have been identified.

3. Develop and keep a record of actions that have been taken.

4. Explain how company’s advisory notices should be released and managed.

5. Keep a record of actions taken when advisory notices are issued.

Clause 8.3.4 Rework

1. Explain how product rework should be performed.

2. Clarify how product rework should be verified.

3. Clarify how product rework should be reviewed.

4. Clarify how product rework should be approved.

5. Clarify how product rework should be recorded.

CLAUSE 8.4 Analysis of data

Elaborates analytical requirements as following

1. Plan how your organization is going to evaluate its QMS.

2. Establish procedures to evaluate organizations QMS.

3. Utilize analytical results to improve organizations QMS.

CLAUSE 8.5 Improvement

It is divided into following sub clauses.

CLAUSE 8.5.1 General

1. Recognize any changes that are necessary for improvement.

2. Recognize any changes that maintain QMS stability, adequacy and effectiveness.

3. Recognize any changes that are needed to ensure medical device safety and performance.

4. Initiate changes that must be made.

CLAUSE 8.5.2 Corrective action

1. Document corrective action procedure.

2. Explicate how actual problems will be investigated.

3. Explain how corrective actions will be developed.

4. Explain how corrective actions will be verified.

5. Explain how corrective actions will be taken.

6. Explain how corrective actions will be reviewed.

7. Implement organizations corrective action procedure.

8. Keep records of corrective actions made.

CLAUSE 8.5.3 Preventive action

1. Document preventive action procedure.

2. Explicate how actual problems will be investigated.

3. Explain how preventive actions will be developed.

4. Explain how preventive actions will be verified.

5. Explain how preventive actions will be taken.

6. Explain how preventive actions will be reviewed.

7. Implement organizations preventive action procedure.

8. Keep records of preventive actions made.

IMPORTANT 

TERMINOLOGIES

Correction: Occurs when you discover a problem and implement an immediate fix to allow the work to continue.

Corrective action: Discovers the root cause and correct it to prevent the problem from occurring again in the future.

Preventive action: Correct the root cause of potential non conformity. It means when a worker judges some problem in the process and correct it before that process can create non conformity. That problem can be a root cause for various defects.

 

Now I hope you have acquired some knowledge about CLAUSE 8 in ISO 13485:2016. We will see in detail about different topic related to healthcare in our next blog.

NOTE: Dear friends!!! ...Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


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If you find this blog post knowledgeable, comment & share it with a friend! 

 

 

 


Thursday, June 25, 2020

ISO 13485:2016 MEASUREMENT, ANALYSIS AND IMPROVEMENT - PART 1

Hi friends!!!

In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6, CLAUSE 7. Please check out for the links given below.

CLAUSE 4

CLAUSE 5

CLAUSE 6

CLAUSE 7 - PART 1

CLAUSE 7 - PART 2

Today we are going to see about CLAUSE 8 of ISO 13485;2016. In order to make the learning easy we will split the CLAUSE 8 into two separate blogs.

Let’s get into the topic with a small introduction about ISO 13485;2016.

WHY ISO 

13485:2016?

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements. Such organisations can be involved in Design & Development of Medical Device, Production, Storage  and Distribution, Installation and Servicing of Medical Device or provision for other associated activities (eg: Technical Support).


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 CLAUSE 8 MEASUREMENT, ANALYSIS 

AND IMPROVEMENT

It is divided into following sub clauses.

CLAUSE 8.1 General

CLAUSE 8.2 Monitoring and measurement

CLAUSE 8.3 Control of non-conforming product

CLAUSE 8.4 Analysis of data

CLAUSE 8.5 Improvement


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We will discuss in detail about each clauses individually.

IMPORTANT TERMINOLOGIES

MEASUREMENT

Allocation of numbers to performance, events or objects.

MONITORING

Done to verify compliance or non-compliance of a process or product.

ANALYSIS

Uses data to discover patterns, relationship and trends.

CLAUSE 8.1 General

Plan processes related to monitoring, measurement and analysis.

Plan how monitoring methods will be utilized to confirm conformity and effectiveness.

Plan how measurement will be utilized to confirm conformity and effectiveness.

Plan how analysis will be utilized to confirm conformity and effectiveness.

CLAUSE 8.2 Monitoring and measurement

It is again divided into following sub clauses.

CLAUSE 8.2.1 Feedback

1. Develop feedback methods and procedures.

2. Assess the information organization has gathered.

3. Utilize feedback to measure QMS effectiveness.

4. Utilize feedback to facilitate risk management.

5. Utilize feedback to support improvement process.

6. Utilize feedback to enhance product realization.

CLAUSE 8.2.2 Complaint handling

1. Develop organizations complaint handling procedure.

2. Document organizations complaint handling procedure.

3. Implement organizations complaint handling procedure.

4. Keep organizations complaint handling procedure.

5. Maintain organizations complaint handling procedure.

CLAUSE 8.2.3 Reporting to regulatory authorities

1. Develop reporting procedures when regulators expect your organization to report to them.

2. Document reporting procedures when regulators expect your organization to report to them.

3. Implement reporting procedures when regulators expect your organization to report to them.

4. Keep reporting procedures when regulators expect your organization to report to them.

CLAUSE 8.2.4 Internal audit

1. Develop your organizations internal audit procedure.

2. Plan your organizations internal audit process.

3. Carryout your organizations internal audit process.

4. Keep your organizations internal audit process.

5. Eliminate all non conformities and its causes.

6. Follow up on measures implemented to resolve non conformities.

CLAUSE 8.2.5 Monitoring and measurement of processes

1. Find out whether process achieved intended results.

2. Develop proper methods to monitor and measure each QMS process.

3. Apply suitable methods to monitor and measure each QMS process.

CLAUSE 8.2.6 Monitoring and measurement of product

1. Monitor and measure organizations product characteristics.

2. Establish record of product monitoring and measurement activities.

3. Complete all planned arrangements before the product is released.

 

Now I hope you have acquired some knowledge about CLAUSE 8 in ISO 13485:2016. We will see in detail about other sub clauses of CLAUSE 8 in next blog.

NOTE: Dear friends!!! ...Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


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Monday, June 22, 2020

ISO 13485:2016 PRODUCT REALIZATION - PART 2

Hi friends!!!

In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6, CLAUSE 7 of  ISO 13485:2016. Please check out for the links given below.

CLAUSE 4

CLAUSE 5

CLAUSE 6

CLAUSE 7 - PART 1

Today we are going to see remaining sub clauses of CLAUSE 7 – ISO 13485:2016.

Let’s get into the topic with a small introduction about ISO 13485:2016.

WHY ISO 

13485:2016?

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements. Such organisations can be involved in Design & Development of Medical Device, Production, Storage  and Distribution, Installation and Servicing of Medical Device or provision for other associated activities (eg: Technical Support). 


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CLAUSE 7 PRODUCT REALIZATION

It  is divided into following sub clauses.

Clause 7.1 Planning of product realization. 
Clause 7.2 Customer related process.
Clause 7.3 Design and Development.
Clause 7.4 Purchasing.
Clause 7.5 Production and service provision.
Clause 7.6 Control of monitoring and measuring equipment.


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We have seen about CLAUSE 7.1, CLAUSE 7.2, CLAUSE 7.3 in previous blog. Let's discuss about remaining sub clauses.

CLAUSE 7.4 PURCHASING

It is divided into following sub clauses.

CLAUSE 7.4.1 Purchasing process

1. Develop procedures to control product purchases.

2. Develop supplier evaluation and selection criteria.

3. Develop supplier monitoring and re-evaluation.

4. Monitor performance of company’s suppliers.

5. Act whenever supplier fails to meet purchasing requirements.

6. Develop supplier evaluation, selection and monitoring records.

CLAUSE 7.4.2 Purchasing information

1. Plan organizations product purchases.

2. Review organizations purchase requirements before sharing them.

3. Maintain organizations purchasing documents and records.

CLAUSE 7.4.3 Verification of purchased product

1. Develop methods and activities to verify purchased product.

2. Make arrangements to verify purchased product.

3. Verify whether organizations purchased product meets purchase requirements.

4. Consider what to do when changes are made to purchased products.

5. Establish and maintain a record of purchased product verification.

CLAUSE 7.5 Production and service provision

It is divided into following sub clauses.

CLAUSE 7.5.1 Control of production and service provision

1. Plan organizations production and service provision.

2. Carry out organizations production and service provision.

3. Monitor organizations production and service provision.

4. Control organizations production and service provision.

CLAUSE 7.5.2 Cleanliness of the product

1. Identify product that organization clean prior to sterilization process.

2. Document and maintain organizations cleanliness or contamination requirements for products that you clean prior to sterilization or use.

3. Identify product that organization cannot clean prior to sterilization process.

4. Document and maintain organizations cleanliness or contamination requirements for products that you cannot clean prior to sterilization or use.

5. Identify products supplied non sterile to be cleaned before sterilization or use.

6. Document and maintain organizations cleanliness or contamination requirements for products that are supplied non sterile to be cleaned before sterilization or use.

7. Identify process agents that must be removed from products during manufacturing.

8. Document process agents that must be removed from products during manufacturing.

CLAUSE 7.5.3 Installation activities

1. This clause specifies product installation and verification requirements.

2. Establish medical device installation requirements.

3. Document organizations medical device installation requirements.

4. Establish medical device installation verification requirements.

5. Document organization medical device installation verification requirements.

CLAUSE 7.5.4 Servicing activities

1. Develop medical device servicing procedures & reference materials.

2. Document organization procedures & materials to control medical device servicing activities.

3. Use organization procedures and materials to control medical device servicing activities.

4. Maintain a record of organizations medical device servicing activities.

5. Recognize improvement opportunities and servicing complaints.

CLAUSE 7.5.5 Particular requirements for sterile medical devices

1. Develop record of organizations sterilization process parameters.

2. Record sterilization parameters for each batch of medical devices.

CLAUSE 7.5.6 Validation of processes for production & service provision

1. Develop procedures to validate production and service delivery process and software applications that could influence products & services.

2. Validate process and software application that could influence products and services.

3. Recognize process that generate output that cannot be verified by subsequent monitoring and measurement until it’s too late.

CLAUSE 7.5.7 Particular requirements for validation of process for sterilization and sterile barrier systems

1. Develop procedures used to validate process for sterilization and sterile barrier system.

2. Document procedures used to validate process for sterilization and sterile barrier system.

3. Apply procedures used to validate process for sterilization and sterile barrier system.

4. Maintain procedures used to validate process for sterilization and sterile barrier system.

CLAUSE 7.5.8 Identification

1. Develop procedures and systems to control the unique identity of medical devices.

2. Document procedures and systems to control the unique identity of medical devices.

3. Implement procedures and systems to control the unique identity of medical devices.

CLAUSE 7.5.9 Traceability

It is further divided into following sub clauses.

CLAUSE 7.5.9.1 Establish suitable product traceability procedures

1. Develop organization product traceability procedures.

2. Implement organization product traceability procedures.

3. Maintain organization product traceability procedures.

CLAUSE 7.5.9.2 Establish suitable records for implantable devices

1. Establish organizations traceability records for implantable medical devices.

2. Direct suppliers of distribution services to have distribution records.

CLAUSE 7.5.10 Customer property

1. Recognize property supplied by customers to be utilized by medical devices.

2. Verify property supplied by customers to be utilized by medical devices.

3. Protect property supplied by customers to be utilized by medical devices.

4. Keep a record of customer property that is lost, damaged or unsuitable.

5. Communicate lost, damaged or unsuitable customer property to customers.

CLAUSE 7.5.11 Preservation of product

1. Establish procedure to preserve conformity of products.

2. Document and maintain procedures to preserve conformity of products.

3. Prevent medical device damage, alteration and contamination.

4. Protect products when exposed to hazards and expected conditions.

CLAUSE 7.6 Control of monitoring and measuring equipment

1. Identify and recognize monitoring and measurement requirement.

2. Choose proper monitoring and measurement requirement.

3. Develop organizations monitoring and measurement procedures.

4. Prepare organizations calibration and verification plans & procedures.

5. Safeguard organizations monitoring and measurement equipment.

6. Establish monitoring and measurement software procedures.


Now I hope you have acquired some knowledge about CLAUSE 7 in ISO 13485:2016. We will see in detail about other CLAUSE 8 in next blog.

NOTE: Dear friends!!! ...Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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Saturday, June 20, 2020

ISO 13485:2016 PRODUCT REALIZATION - PART 1

Hi friends!!!

In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6 of ISO 13485:2016. Please check out for the links given below.

CLAUSE 4

CLAUSE 5

CLAUSE 6

Today we are going to see about CLAUSE 7 of ISO 13485:2016. In order to make the learning easy we are going to divide the contents of CLAUSE 7 into two separate blogs.

Let's get into the topics with a introduction about ISO 13485:2016.

WHY ISO 13485:2016?

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements. Such organisations can be involved in Design & Development of Medical Device, Production, Storage  and Distribution, Installation and Servicing of Medical Device or provision for other associated activities (eg: Technical Support).


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CLAUSE 7 PRODUCT REALIZATION

It  is divided into following sub clauses.

Clause 7.1 Planning of product realization. 
Clause 7.2 Customer related process.
Clause 7.3 Design and Development.
Clause 7.4 Purchasing.
Clause 7.5 Production and service provision.
Clause 7.6 Control of monitoring and measuring equipment.


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CLAUSE 7.1 Planning requirements

1. Plan QMS processes that are required to realize products.
2. Develop QMS processes that are required to realize products. 
3. Establish risk management processes for product realization.
4. Plan how is your organisation going to realize each product.
5. Device quality objective for medical products.
6. Explain particular product realization requirement.
7. Produce product realization planning output.
8. Maintain records of product realization activities.
  
CLAUSE 7.2 Customer related process

It is again divided into following sub clauses.

CLAUSE 7.2.1 Determine product requirements

1. Recognize requirement provided by customers, products intended use, regulatory bodies, organisation itself.

CLAUSE 7.2.2 Review your product requirements

1. Assess product requirements before organisation accept orders.
2. Review product requirements before organisation supplies products.
3. Record organisation product requirement reviews .
4. Verify product requirements before organisation agrees to make orders. 
5. Confirm that product requirements can be fulfilled before organisation proceeds.

Clause 7.2.3 Communicate product requirements 

1. Plan arrangements to communicate with customers.
2. Document organisation customer communication arrangement.
3. Implement organisation customer communication arrangement.
4. Keep organisation customer communication arrangement.
5. Develop arrangement to communicate with regulatory authorities.
6. Employ organisation arrangements to communicate with regulatory authorities.

CLAUSE 7.3 Design and development 

It is again divided into following sub clauses.

CLAUSE 7.3.1 Prepare Design and Development procedures

1. Organisation required to document all the logical phases in design and development in a well structured procedure.
2. Defining responsibilities for different activities, including approving authorities.

The requirement of standard are:

1. Develop procedures for design and development.
2. Document procedures for design and development.

CLAUSE 7.3.2 Organize and plan Design and Development activities

1. Avoid unnecessary delays.
2. Prepare goals and objectives of design and development of product.
3. Breakdown of major activities includes timeline for each activity and whole project, risk management activities and allocation of resources needed in each phase of design and development.

The requirement of the standard are:

1. Plan the design and development of Organisation medical products.
2. Document the design and development of organisations medical products plan.
3. Maintain the design and development of Organisation planning document.
4. Control design and development of Organisation medical product.

CLAUSE 7.3.3 Determine Design and Development input

Design inputs can be decided based on the following factors.

1. Intended application.
2. Customer requirements.
3. Ergonomics & safety features.
4. Risk control & risk mitigation techniques.
5. Past complaints, failure reports, adverse events of similar products.
6. Usability requirements. Example: application, preservation, handling and maintenance.
7. Physical features, attributes and manufacturing feasibility.
8. Relevant regulatory, legal and statutory needs and appropriate standards.
9. Sterilization requirements and servicing needs.
10. Economic study and costing feasibility.

The requirements of the standard are:

1. List all the products design and development inputs.
2. Review all the products design and development inputs.
3. Approve all the products design and development inputs.
4. Keep a record of design and development inputs.

CLAUSE 7.3.4 Generate Design and Development output

Organisation can produce design output in the following forms

1. Raw materials, components parts, sub-assemblies and finished device specification in drawing.
2. Manufacturing process and environment specification.
3. Procedure for quality assurance that explains acceptance criteria.
4. Product identification, traceability, manufacturing, packaging and inspection procedures.
5. Documentation for submission to the regulatory authorities where devices will be marketed.
6. Design history file to demonstrate that design was verified and validated.

The requirements of this standard are same as CLAUSE 7.3.3               

CLAUSE 7.3.5 Carry out Design and Development reviews

1. Address number of manufacturing and customer concerns.
2. Check whether design meets product requirement or not.
3. Check whether device exhibits compatibility with processing capabilities or not.
4. Check whether safety concerns are addressed or not.
5. Check whether device is environment friendly or not.
6. Check whether service elements are adequate or not.
7. Minutes of meeting shall be maintained.

The requirements of the standard are:

1. Plan organizations design and development reviews.
2. Perform reviews in accordance with planned arrangements.
3. Maintain records of organisations design and development reviews.

CLAUSE 7.3.6 Perform Design and Development verification

Make sure design inputs matches the design output. Organisation can verify design with the help of lab tests, chemical analysis, substitute calculations, comparing designs, inspections & review of documents like specification records, drawings, procedures, plans & reports.

The requirements of the standard are:

1. Plan organisations design and development verification activities.
2. Document organisations design and development verification plan activities.
3. Perform verification in accordance with planned arrangements.
4. Maintain records of organizations design and development verification activities.

CLAUSE 7.3.7 Conduct Design and Development validation

Make sure medical device confirms to end user requirements. Validation is done on samples of initially produced lots. Validated in stimulated condition where its actual performance can be tested. Example: Clinical testing of medical device.

The requirements of this standard are same as CLAUSE 7.3.6.

CLAUSE 7.3.8 Manage Design and Development transfers

1. Document a procedure to transfer design and development outputs to manufacturing. Product development has to make sure that design can be translated to production and records of such transfers are maintained.

The requirements of the standard are:

1. Develop procedures.
2. Employ organisations procedures.
3. Record design and development transfer results and conclusions.

CLAUSE 7.3.9 Control Design and Development changes

Design changes can be needed at any time based on review, verification, validation, complaints, risk mitigation, manufacturing issues. Prior to change enforcement it should be reviewed, verified, validated and approved against design inputs and requirements.

The requirements of this standard are same as CLAUSE 7.3.8.

CLAUSE 7.3.10 Maintain Design and Development files

Includes reference records for conformity to design requirements, records of review, verification, validation and changes.


Now I hope you have acquired some knowledge about CLAUSE 7 in ISO 13485:2016. We will see in detail about other sub clauses of CLAUSE 7 in next blog.

NOTE: Dear friends!!! ...Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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