Thursday, October 22, 2020

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.



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.



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


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


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 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.



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 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.


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).


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.


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.

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