The MDSAP in 2022: Policies, Procedures and Developments
For devicemakers hoping to enter the global market, the Medical Device Single Audit Program (MDSAP) is a must.
MDSAP success can get your devices to market faster and it precludes being subject to routine FDA inspections, leading to a much less stressful relationship with the FDA.
The MDSAP in 2022: Policies, Procedures and Developments has everything you must know about the workings of MDSAP audits, new developments and strategies for success.
In the past three years alone, a multitude of procedures have been refined and Argentina, the Republic of Korea and Singapore have joined the U.S., Australia, Canada, Japan and Brazil — with more on the way. The MDSAP in 2022 provides a comprehensive view of the current state of MDSAP, enabling you to reap the vast potential of the program.
This report details the program’s principles and procedures, policy developments in individual countries, guidance from the FDA and more. It has the up-to-date intelligence you need to help you make the most of your resources and come through your audits with top marks.
The MDSAP in 2022 shows you the specifics of how MDSAP audits work, including details about frequency, duration and areas of scrutiny. It explains how to prepare for them by taking advantage of resources that guide the auditors themselves. And it pinpoints which regulators require them, which may be about to make them mandatory and the benefits of voluntary participation.
Management report takeaways:
- What has changed in the past three years: which countries are participating in MDSAP and which of those require an MDSAP audit
- How MDSAP audits can be conducted remotely
- The different types of audits involved, such as initial certification, surveillance, desk and onsite audits
- The standard schedule for and duration of audits
- Specific areas auditors will examine and questions they will ask
- How to use the MDSAP companion document to create an audit preparation checklist that matches the auditors’ process
- The MDSAP grading system and how nonconformance issues can be escalated — and the consequences of getting a bad grade
- Costs of an MDSAP audit
Bonus: Includes copies of the MDSAP manual and its companion document for step-by-step instructions, guidance from the FDA on remote MDSAP audits, a guide to the program’s nonconformity grading scale and other valuable resources.
You can save time, effort and money by using MDSAP. Maximize your success with The MDSAP in 2022: Policies, Procedures and Developments.
About the Contributor
Connie Hoy is a former EVP of regulatory, quality and clinical development at Cynosure, a division of Hologic, with three decades of experience in the medical device industry. Since leaving Cynosure in 2018, Ms. Hoy has led a number of companies through the process of obtaining MDSAP certification. She also performs internal audits that meet the requirements of MDSAP.
Who Will Benefit
- Regulatory/compliance staff
- Quality managers
- Senior executives
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