The Medical Device Single Audit Program (MDSAP) is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
DNV as a designated auditing organization offers the combined MDSAP certification process with ISO 13485 and/or EU MDR CE Certification process.
Based on ISO 13485:2016 the MDSAP was developed by representatives of:
- Australian Therapeutic Goods Administration (TGA),
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA),
- Health Canada,
- MHLW/PMDA, and
- the U.S. Food and Drug Administration (FDA).
This webinar will be opened to everyone within the medical sector and aims to provide an in-depth understanding related to the general requirements of MDSAP, the purpose of the scheme, different applicable scenarios for combination with ISO 13485 and/or EU MDR certification processes, and a dedicated Q&A section to answer your queries.
- Introduction to MDSAP
- Reviewing MDSAP requirements
- Combination with ISO 13485
- Combination with EU-MDR
- How to make the decision making
- How DNV could support medical device manufacturers
- Q&A Session
Hasan Zarin Mehr
Senior Lead Auditor, Supply Chain & Product Assurance, DNV Australia
Hasan is the Senior Lead Auditor and Medical Device Assessor for MDR 2017/745, ISO 13485 and MDSAP for Australia and New Zealand. With more than 18 years’ experience in medical device industry, Hasan has gained many experiences in Regulatory requirements, Audits and Assessments.
Before joining DNV, he worked as a Medical Device Technical Specialist, QMR/QA/RA and has worked with vast range of medical device manufacturers for providing technical files for CE-Certification including active & non-active devices in all classes of Is, Im, IIa, IIb and III, as well as implementing Quality Management System in accordance with ISO 13485.
Do register your interest for this webinar and we look forward for your participation.