Medical Device Single Audit Program (MDSAP)
Maximise Your Market Presence with MDSAP Certification
Streamlining Compliance for Global Expansion
In the rapidly evolving medical device sector, expanding your market reach is crucial. The Medical Device Single Audit Program (MDSAP) offers an efficient pathway for companies aiming to broaden their global footprint. By consolidating the Quality Management System (QMS) certification process, MDSAP allows medical device companies to comply with regulatory requirements across multiple key markets via a single audit program.
MDSAP’s alignment with 21CFR 820, ISO 13485 standards, supplemented by additional QMS requirements for participating countries, empowers your business to fulfill regulatory mandates in five significant markets:
- Australia
- Brazil
- Canada (exclusively recognising MDSAP audits post-December 31, 2018)
- Japan
- United States
Tailoring Your MDSAP Certification Strategy
Choosing to pursue MDSAP certification necessitates a strategic approach. Manufacturers should apply for certification specifically in markets where they currently market or intend to market their devices. It’s crucial to align your MDSAP certification scope with both your immediate compliance needs and your long-term business goals. Expanding your certification to encompass additional member markets may entail adjustments to your QMS, including the augmentation of technical documentation and undergoing recertification.
Ensuring Audit Success with Comprehensive Gap Analysis
QAEC Limited specialises in evaluating your Quality Management System’s readiness for the MDSAP audit through a thorough Gap Analysis. This analysis pinpoints the essential steps your company must undertake to achieve MDSAP certification. Our expertise extends to conducting independent internal audits to assess conformity with ISO 13485:2016, alongside the quality and regulatory requirements of Australia, Brazil, Canada, Japan, and the United States. Understanding each country’s unique standards and regulations is key to navigating your regulatory pathway successfully. We pride ourselves on having successfully integrated MDSAP within organisations’ QMS, facilitating medical device marketing authorisation and facility registration across the globe.
Embark on Your MDSAP Journey with Us
Reach out to us today at 01452 341913 or enquiries@qaeclimited.co.uk to discuss how we can support your MDSAP certification needs.
To discover how our expertise can streamline your path to global market access: