Are you preparing for the Medical Device Single Audit Program (MDSAP) audit process?

The International Medical Device Regulators Forum (IMDRF) perceives that a worldwide way to deal with examining and checking the manufacturing of medical devices could improve their security and oversight on a global scale. At its debut meeting in Singapore in 2012, the IMDRF recognized a work gathering to create explicit reports for propelling a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program permits an MDSAP perceived Auditing Organization to lead a single regulatory audit of a medical device maker that fulfils the pertinent necessities of the regulatory authorities taking an interest in the program.

International partners that are taking an interest in the MDSAP include:

• TGA -Therapeutic Goods Administration of Australia
• ANVISA -Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada – Canada
• MHLW – Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• FDA – USA
• The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers

The audit of MDSAP depends on 13485:2016 with the appropriate regulatory necessity of the interested authority – Australia, Canada, Japan, Brazil, USA – included as regions of core interest. The MDSAP Companion Document distinguishes the audit work that must be secured and the connections to the appropriate regulatory prerequisites for interested authority. The guidance material for MDSAP audits is accessible on the US FDA site under CDRH Learn (go to Quality Systems – Inspections – Global Harmonization). MDSAP reports are likewise openly accessible to all.

The new annexes are titled as follows:

• Audit of Product/Process related Technologies and Technical Documentation
• Audit of Requirements for Sterile Medical Devices
• Medical Device Adverse Events and Advisory Notices Reporting Process Quick Reference
• Requirements for Written Agreements
• Medical Device Single Audit Program background and current adoption status

There should be a focus on a productive report on updating and sharing for the ones if your organization is over various locations. (In this case where a medical device certain QMS software can truly help). The emphasis will be on your essential site, which is the place most of the audit will be held. This is any way of which procedures are off-site and incorporates virtual manufacturers. The actual audits will start with the management audit. This incorporates your management audit, processes, quality manual and approach, record control, marketing clearances and licenses. Examiners are keen on comparable things which are incorporated into FDA inspections or ISO audits.

Read More -  Medical Device Single Audit Program

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