BENEFITS OF THE ALL IN ONE MDSAP AUDIT MODEL (02.03)

Rami.Azulay May 16th, 2020 Posted by Rami Azulay( ) Requirements Management Tool

According to the FDA, the MDSAP pilot audit was developed to cover existing requirements from the regulatory authorities participating in the MDSAP Pilot in order to facilitate an all in one audit.

Apart from the existing requirements by the ISO13485: 2016 and the medical device regulations from the participating regulatory authorities the program does not include any further requirements.

The audit incorporates the following

  • ISO 13485: 2016 – Medical devices Quality management systems; Requirements for regulatory purposes
  • Quality System Regulation (21 CFR Part 820)
  • Brazillian Good Manufacturing Practices (RDC ANVISA 16/2013)
  • Licensing, Registration, Advisory notices as well as other specific requirements as medical device regulatory authorities participating in the MDSAP pilot program.

MANUFACTURERS BENEFITS OF PARTICIPATING IN MDSAP PILOT

In the United States, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health allow the use of the MDSAP Pilot report as a suitable alternative for the FDA routine inspections.

Furthermore, the certification documents issued by the auditing organization communicate compliance with applicable US regulations which may provide a marketing advantage.

MDSAP PILOT GOALS AND FUTURE MDSAP USE

The purpose of MDSAP and its Pilot Program goals are parallel to each other such as

  1. To improve medical device safety and oversight with the help of various international bodies across all borders.
  2. To provide a single audit program that provides confidence to international regulators
  3. To effectively reduce the regulatory burden on the medical device industry by enabling Government regulatory authorities to focus on problematic manufacturers. Thus, allowing notified bodies to carry out inspections on their behalf
  4. To promote a more efficient and less burdensome regulatory oversight of manufacturers medical device quality management systems
  5. To endorse a proper and effective utilization of regulatory resources through mutual acceptance and division of labor among regulators
  6. Finally, to encourage better global alignment of regulatory approaches and technical requirements based on agreed standards and best practices.

 

MDSAP PILOT AUDIT MODEL ONLINE

All the necessary Information about the MDSAP Pilot Audit Model is available online. Other documents specific to the MDSAP Pilot can be easily accessed on the FDA website. The government documents N3, N4, N5, N6, and N11 which specify the requirements for regulatory authorities, the auditing organizations, and also serve as the basis for the MDSAP pilot are all accessible on the IMDRF website.

 

FDA SITE-SPECIFIC ONLINE INFORMATION FORMS

There are several online resources provided by the FDA that provide more information about the MDSAP Pilot Program and this include

  • MDSAP FAQs
  • Pilot Program Announcements
  • Program Announcements
  • MDSAP Audit Procedures and FORMS
  • Eligible Auditing Organization
  • Follow up online to learn more

MDSAP ONLINE POLICIES, PROCEDURES, TEMPLATES, AND FORMS

All policies, templates, procedures, and forms for MDSAP can be found online at the FDA’s website at both of the following locations below

Visit FDA web site: https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-policies-procedures-templates-and-forms

MDSAP, FDA and ANSA Question and Answer Site

The MDSAP Question and Answer Information is already integrated into the course but for future references, you can check out the link below for more information

Here is the link:  http://portal.anvisa.gov.br/documents/33864/2869776/Medical+Device+Single+Audit+Program+-+Frequently+Asked+Questions/b33795ba-8bbd-45a3-acd2-8c2c5e9976f2?version=1.1

MDSAP DOCUMENT FOR AUDIT ASSESSMENT

The following documents below are used for the actual audit and can be accessed at the FDA site online

Here is the link to the FDA site online: https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-procedures-and-forms

 


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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