MDSAP Management Process Audit - Part 3

 Hi friends!!!

In our previous blog we had a introduction about Medical Device Single Audit Program and MDSAP Audit Cycle. Please check out for the link below.

Medical Device Single Audit Program - Part 1

MDSAP Audit Cycle - Part 2

In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) Management Process Audit 

MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.

Let's get into the topic.

MANAGEMENT PROCESS AUDIT

The purpose of auditing the management process is to ensure whether the top management demonstrated a necessary commitment to establish a effective quality management system. There are totally 11 tasks to be performed during management process audit. The tasks are as follows.

 

Task 1: QMS Planning, Implementation, Changes and Quality Manual.

Task 2: Management Representative.

Task 3: Quality Policy and Quality Objectives.

Task 4: Organizational Structure, Responsibility, Authority and Resources.

Task 5: Extent of Outsourcing.

Task 6: Personnel Competency and Training.

Task 7: Risk Management Planning and Review.

Task 8: Document and Record Controls.

Task 9: Management Reviews.

Task 10: Distribution of Devices with Appropriate Marketing Authorization.

Task 11: Top Management Commitment to Quality.

Let’s discuss in detail about each task.

Task 1: QMS Planning, Implementation, Changes and Quality

Manual

Confirm QMS planning is done to ensure all processes are identified, documented, implemented, monitored and controlled in order to confirm to applicable regulatory requirements. Verify whether changed in QMS are managed to maintain the conformity of QMS. Verify that the quality manual is documented.

When there is a change in QMS to continue to be effective, quality planning in this regard should satisfy clause 7.1. of ISO 13485;2016.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016. Clause 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.2.2, 5.4.2.

FDA: 21 CFR 820.20.

TGA: TG(MD)R Sch3 P1 1.4(4).

ANVISA: RDC ANVISA 16/2013: 2.1, 5.6.

MHLW/PMDA: MHLW MO169: 5, 7, 14.

Task 2: Management Representative

Verify whether Top Management has documented the appointment of Management Representative. Verify the responsibilities of Management representative. Ensure that responsibilities include reporting to top management on the performance of organizations QMS and promotion of applicable regulatory requirements throughout the medical device organization.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016. Clause 5.5.2.

FDA: 21 CFR 820.20(b).

TGA: TG(MD)R Sch3 P1 1.4(5)(b)(ii).

ANVISA: RDC ANVISA 16/2013: 2.2.5.

MHLW/PMDA: MHLW MO169: 16.

Task 3: Quality Policy and Quality Objectives

Check whether quality policy and objectives are set for all functions and levels of medical device organization. Ensure that quality objectives are measurable and in accordance with quality policy. Confirm the measures taken to achieve quality objectives.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016. Clause 5.3, 5.4.1.

FDA: 21 CFR 820.20(a).

TGA: TG(MD)R Sch3 P1 1.4(5)(a).

ANVISA: RDC ANVISA 16/2013: 2.2.1.

MHLW/PMDA: MHLW MO169: 12, 13.

Task 4: Organizational Structure, Responsibility, Authority and 

Resources

Check the medical device organizations structure and related documents to ensure that they include provisions for authorities, responsibilities, infrastructure, competencies and training to ensure that the personnel employed should have the necessary competence to design and manufacture medical devices in accordance with applicable regulatory requirements.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 5.1, 5.5.1, 5.5.2, 6.1, 6.2.

FDA: 21 CFR 820.20(b), 820.25.

TGA: TG(MD)R Sch3 P1 1.4(5)(b).

ANVISA: RDC ANVISA 16/2013: 2.2.2, 2.2.3. 2.2.4, 2.3.

MHLW/PMDA: MHLW MO169: 10, 15, 16, 21, 22, 23.

Task 5: Extent of Outsourcing

Check that the critical suppliers list is current and accurate. Specify the extent of outsourcing with respect to applicable regulatory requirements. Verify the documentation of controls in organizations QMS.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.5, 4.2.1.

FDA: 21 CFR 820.50.

TGA: TG (MD)R Sch3 P1 1.4(5) (b)(iii), (d)(ii).

ANVISA: RDC ANVISA 16/2013: 2.5.

MHLW/PMDA: MHLW MO169: 5, 6

Now I hope you have acquired some knowledge about MDSAP Management Process Audit.  We will discuss in detail about remaining tasks of management process audit in our future blogs.

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

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Generations of CT Scanners

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components of x ray tube

MRI scan 

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

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MDSAP Audit Cycle - Part 2

 Hi friends!!!

In our previous blog we had a introduction about Medical Device Single Audit Program. Please check out for the link below.

Medical Device Single Audit Program - Part 1

In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) Audit Cycle

MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.

Let's get into the topic.

WHAT IS MEDICAL DEVICE SINGLE

AUDIT PROGRAM?

The Medical Device Single Audit Program (MDSAP) is a program that allows performing a single audit of a medical device manufacturer’s quality management system which satisfies the requirements of multiple regulatory bodies. The MDSAP Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities (Participating countries) to audit under MDSAP requirements.

 

WHAT IS MDSAP AUDIT CYCLE? 

The MDSAP follows a three-year audit cycle. During the first year, it starts with Initial Audit.

INITIAL AUDIT

The Initial Audit is also known as Initial Certification Audit. It has two stages, stage 1 and stage 2.

STAGE 1

The stage 1 audit is done for documentation review and evaluation of preparedness for stage 2 audits. The stage 1 audit is performed in accordance with clause 9.3.1.2. of  ISO/IEC 17021-1:2015 and all applicable MDSAP audit process.

QMS documents with respect to clause 4.2.1 of ISO 13485:2016 and other MDSAP documents should be defined and documented. The preparedness of medical device organization for stage 2 audit is reviewed. The main emphasis is on the planning of stage 2 audit. The information is collected on the scope of Quality Management System and other aspects of medical device organization.

The stage 1 audit can be performed at a site other than the site of medical device organization seeking for an initial certification. The auditing organization can combine stage 1 and stage 2 audit as a single on-site visit for the initial audit of medical device organization.

 

STAGE 2

The stage 2 audit is performed to evaluate the implementation of QMS and its effectiveness. The stage 2 audit is performed in accordance with clause 9.3.1.3 of ISO/IEC 17021-1:2015 and all applicable MDSAP audit process. The stage 2 audit determine if the requirements of ISO 13485:2016 and other regulatory requirements of participating regulatory authorities have been implemented.

The stage 2 audit evaluated the effectiveness of medical device organization’s QMS in fulfilling the applicable regulatory requirements. Evaluated the technologies related to product and processes. Adequacy of product technical documentation will be evaluated and medical device organizations ability to comply with these requirements will also be evaluated.

The auditing organization should evaluate the medical device organization’s evidence to demonstrate its devices meet essential principles of safety, performance and effectiveness.

SURVEILLANCE AUDIT

The surveillance audit is performed during the second and third year of audit cycle. The surveillance audit should review the issues related to medical device safety and effectiveness since the conduct of last audit such as vigilance reports, complaints, recalls, field actions, corrective actions.

The objectives of surveillance audits include evaluating the effectiveness of medical device organization’s QMS incorporating the applicable requirements. Evaluates the new or changed product, process, and technical documentation. The surveillance audits do not require stage 1 audit unless significant change has been made since the last audit.

During audit if there is an indication of potential non conformity, the further audit of the individual processes like design and development process, production and service controls process should focus on those identified non conformity.

If the first surveillance audit focusses on the design and development process, the second surveillance audit should focus on production and service controls process (or vice versa).

RECERTIFICATION AUDIT

The recertification audit is done in accordance with clause 9.6.3 of ISO/IEC 17021-1:2015 and all MDSAP audit process tasks.

The main objective of re-audit is to check and confirm the continued relevance, applicability and suitability of medical device organization’s QMS. Re-audits shall be shorter than initial audits because of selective and focused sampling. All follow-ups of corrections and corrective actions stemming from the findings of pervious MDSAP audits are reviewed.

New or modified design, processes and new products are reviewed. Areas which are not sufficiently covered during the surveillance audits are reviewed. The audits which are done off site should not be recorded on the certificate.

SPECIAL AUDIT

The special audit should be conducted in accordance with the requirements of ISO/IEC 17021-1:2015 and other applicable MDSAP requirements.

The special audits are conducted in case of an application for the extension of the scope of existing certification, to determine the grant or rejection of the extension. The special audits are also conducted in case of the investigation of significant complaints or suspect of serious non conformity.

The special audit can be conducted when there is an insufficient audit time or inappropriate audit team during pervious audit. The auditing organization shall submit the audit reports to regulatory authorities within 15 days from the last day of audit.

Now I hope you have acquired some knowledge about Medical Device Single Audit Program.  We will discuss in detail about a topic related to Biomedical Engineering  in our future blogs.

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

Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan 

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

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Medical Device Single Audit Program (MDSAP) - Part 1

Hi friends!!!

In our previous blog we have discussed about Ophthalmoscope. Please check out for the link below.

OPHTHALMOSCOPE

In today's blog we will discuss about Medical Device Single Audit Program (MDSAP).

MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.

Let's get into the topic.

WHAT IS MEDICAL DEVICE SINGLE

AUDIT PROGRAM?

The Medical Device Single Audit Program (MDSAP) is a program that allows performing a single audit of a medical device manufacturer’s quality management system which satisfies the requirements of multiple regulatory bodies. The MDSAP Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities (Participating countries) to audit under MDSAP requirements.

 

Audits performed under the MDSAP program will be based on the requirements for risk management. Effective implementation of the risk based approach usually starts with the design and development process, product realization, including the selection of suppliers. It also considers feedback from post-market monitoring and continues until the time the product is decommissioned.

 

The verification of QMS documentation should be performed as part of the pre-audit preparation and documentation review, to minimize the on-site audit time and also to increase  auditor’s familiarity with the medical device organization’s QMS.

 

WHAT ARE THE COUNTRIES

PARTICIPATING IN MDSAP?

The following are the countries participating in MDSAP.

1. Health Canada

2. The Australian Therapeutic Goods Administration (TGA)

3. The Brazilian Health Surveillance Agency or Agência Nacional de Vigilância Sanitária (ANVISA)

4. The Japanese Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

5. The United States Food and Drug Administration (FDA).

 

HOW MDSAP AUDITS CONDUCTED?

 

The MDSAP Audits covers the Medical device – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) and corresponding regulatory requirements of the Australian Therapeutic Goods (Medical Devices) Regulations (SR 236, 2002), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Canadian Medical Device Regulations (CMDR, Part 1), the Japanese QMS ordinance (MHLW MO 169), the Quality System Regulation (21CFR 820), and other country specific requirements.

WHAT IS MDSAP AUDIT SEQUENCE?

The MDSAP Audit sequence has four primary processes which include Management process, Measurement, Analysis and Improvement process, Design and Development process, Production and Service control process along with the links for supporting process of purchasing.

The MDSAP has two additional supporting processes, Device Marketing Authorization and Facility Registration, Medical Device Adverse Events and Advisory Notices Reporting. 

WHAT IS MDSAP AUDIT CYCLE?

 

The Medical Device Single Audit Program follows a three year audit cycle. The first step starts with the Initial Audit, which is also referred to as the Initial Certification Audit. It is a complete audit of a medical device organization’s quality management system (QMS). The Initial Audit consist of a Stage 1 Audit (17021-1:2015 – Cl 9.3.1.2) and a Stage 2 Audit (17021-1:2015 – Cl 9.3.1.3).

 

The initial Audit is followed by a partial Surveillance Audit (17021-1:2015 – Cl 9.6.2.2) in each of the following two years and a complete Re-audit called as a Recertification Audit (17021-1:2015 – Cl 9.6.3.2) in the third year. A recertification audit may also include a Stage 1 audit if there have been significant changes to the QMS that have not been otherwise adequately assessed.

 

Special Audits (17021-1:2015 – Cl 9.6.4.2) are audits Conducted by Regulatory Authorities.

 

Unannounced Audits are potential extraordinary audits that may occur at any time within the audit cycle.

 

WHAT ARE THE ANNEXES?

 

ANNEX 1: 

The annex 1 contains country specific information as to the expectations for the audit of product or process related technologies (other than sterilization – See Annex 2) and the audit of technical documentation as part of the execution of the Audit Tasks.

 

ANNEX 2: 

The annex 2 contains information as to the expectation for the audit of requirements for sterile medical devices.

 

ANNEX 3: 

The annex 3 contains a table showing a summary of time frames for reporting advisory notices and individual adverse event reports in the participating MDSAP jurisdictions.

 

ANNEX 4: 

The annex 4 contains country specific guidance on expectations for various types of written agreements for regulatory purposes.

 

AUDIT OF EXTERNAL SUPPLIERS

 

Auditing Organization has the rights to audit external suppliers of a medical device organization, including corporate suppliers. The medical device organization must have proper controls over outsourced processes that provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

 

The term critical suppliers covers the entities with following functions.

 

1. The suppliers who supply the organization with finished devices. Example: Device, or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labelled, or sterilized.

 

2. The suppliers of products, including services, that impact design outputs that are essential for the proper functioning of the device.

 

3. The suppliers of products and services that require process validation

 

HOW NON CONFORMITIES ARE

HANDLED?

 

Particular attention should be given to the potential interrelationship of the nonconformities observed. Nonconformities identified from the audit should be graded on a scale from 1 - least critical to 5 - most critical, and will be managed according to criteria defined in the document GHTF/SG3/N19:2012, Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange.

Now I hope you have acquired some knowledge about Medical Device Single Audit Program.  We will discuss in detail about a topic related to Biomedical Engineering  in our future blogs.

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

Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan 

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

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OPHTHALMOSCOPE

 Hi friends!!!

In our previous blogs, we have discussed about ISO 14971:2019 Risk Management for Medical Device. Please check out for the link below.

ISO 14971:2019 Risk Management for Medical Device

Risk Analysis, Risk Evaluation & Risk Control

Failure Mode Effect Analysis

In today's blog we are going to discuss about Ophthalmoscope.

The Ophthalmoscope is an important instrument used to examine the inside of the eye. Therefore it is important for every healthcare professionals to know about Ophthalmoscope.

 

Let's get into the topic. 

WHAT IS OPHTHALMOSCOPE?

The Ophthalmoscope is an instrument made up of light source and several small lens. The Ophthalmoscope is used to examine the inside of fundus of the eye and other internal structures. The ophthalmoscope is a coaxial optical system, which means the axis of illumination coincides with the axis of vision into the retina. The ophthalmoscope eliminates the shadows in order to facilitate the examination.

The procedure performed using Ophthalmoscope is called as ophthalmoscopy. The Ophthalmoscopy is also called as funduscopy. This procedure is used to check the condition of retina, optic nerve, vasculature, vitreous humor and other parts of the eye. The Ophthalmoscope produces images with approximately 15 times magnification.

The retina is the only portion of the central nervous system which is visible externally. Similarly, fundus is the only location where vasculature can be visualized.

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OPHTHALMOSCOPE SETTINGS

RED FREE

The red free option in ophthalmoscope is used to view vasculature closely.

BLUE

The blue option in ophthalmoscope is used to view corneal abrasions.

SLIT

The slit option in ophthalmoscope is used to view contour abnormalities of cornea, retina and lens.

GRID

The grid in ophthalmoscope is used to identify the distance between retinal lesions.

LARGE APERTURE

The larger aperture is used to examine dilated pupil after administering mydriatic drops.

MEDIUM APERTURE

The medium aperture is used for non-dilated pupil in a dark room setting.

SMALL APERTURE

The small aperture is used to view constricted pupil in a well-lit room setting.

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WHAT ARE THE TYPES OF

OPHTHALMOSCOPE?

There are two types of ophthalmoscope, they are as following.

DIRECT OPHTHALMOSCOPE

The direct ophthalmoscope is used to produce upright image (unreversed image) of the center of retina at about 15 times magnification. The direct ophthalmoscope is also called as traditional ophthalmoscope.

INDIRECT OPHTHALMOSCOPE

The indirect ophthalmoscope is used to produce the inverted image (reversed image) of the retina at about 2 to 5 times magnification. The indirect ophthalmoscope is also called as panoptic ophthalmoscope.

WHAT ARE THE FEATURES OF

OPHTHALMOSCOPE?

APERTURE DIAL

The aperture dial is used to modify the amount of light passing through the lens.

RHEOSTATIC SWITCH

The rheostatic switch is used to power the light source. It is used to adjust the brightness of the light.

FOCUSING WHEEL

The focusing wheel is used to make adjustment in the focus. The red option is for negative focus and green option is used for positive focus.

LENS SELECTION WHEEL

The ophthalmoscope has multiple lens. The lens selection wheel is used to select the lens desired for performing the procedure.

HOW TO FIND RETINA USING

OPHTHALMOSCOPE?

Direct the ophthalmoscope at 15 degrees from the center and look out for the red reflex. Keep following the red reflex until the retina is visible. While using direct ophthalmoscope, we should pivot the ophthalmoscope angling up, angling down, left and right. In case of indirect ophthalmoscope, we can pivot the ophthalmoscope or ask the patients to look up to view upper retina, look down to view lower retina and look at the light to visualize the macula.

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Now I hope you have acquired some knowledge about Ophthalmoscope.  We will discuss in detail about a topic related to Biomedical Engineering  in our future blogs.

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

Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan 

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

DON’T FORGET TO FOLLOW THIS BLOG PAGE

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