Medical Device Single Audit Program (MDSAP)
MDSAP Structure is framed to use ISO 13485:2016 in-line with Good Manufacturing Practice (GMP) requirements of the various regulatory authorities.
MDSAP is aligned with ISO13485 and includes seven major processes:
- Measurement, Analysis, and Improvement,
- Design and Development,
- Production and Service Controls
- Device Marketing Authorization and Facility Registration, and
- Medical Device Events and Advisory Notices Reporting
Benefits of MDSAP Certification
- Avoid multiple audits covering multiple standard requirements by multiple Certification Bodies in a year.
- Efficient, single audit scheme minimizes business disruptions, reduces costs and saves time.
- Much faster market penetration where traditional regulatory oversight can cause significant delays.
- Unified integrated documents can be maintained on-site with the manufacturer thereby reduce lot of paper work and duplication.
Role of I3CGLOBAL Consultants in MDSAP Certification
- MDSAP qualified lead auditors and experienced consultants.
- On-site and Off-site documentation support.
- MDSAP Awareness and IQA Training to employees.
- Initial MDSAP Internal Audit support.
- GAP Assessment – 700 USD/Man-day.
- Guidance / Support for Fixing GAPS – 400 USD/Man-day.
- Internal Audit – 600 USD/Man-day.
Travel & Accommodation Extra.
How to do medical device risk analysis?
Easy customize word files.