- GAP Analysis
- Fill the GAPS by preparing necessary documents
- Implement procedures
- Calibration and validation wherever necessary
- Understanding your activities and planning for Certification
- Identify certification body
- Invite for Certification
MDSAP Certification: The Medical Device Single Audit Program (MDSAP) is a collaborative program between Australia, Brazil, Canada, Japan, and the US FDA to reduce multiple agencies audit burden on medical device manufacturers by using a single audit in a single year. MDSAP requirements are consistent with 21 CFR 820 and ISO 13485, as are supplemental QMS requirements in participating organizations.
I3CGLOBAL assists manufacturers with implementation advice, GAP analysis, and internal audits to medical device manufacturing or related organizations that have previously practiced any type of QMS or are new to QMS. Our consultants are now MDSAP experts, qualified to conduct MDSAP readiness checks and provide implementation support. Here’s how we can assist:
- Conduct a gap analysis to identify current QMS deficiencies and gaps that are impeding MDSAP implementation.
- Determine simple techniques for integrating ISO 13485: 2016 or FDA 21 CFR 820 in order to upgrade to MDSAP.
- Identify and interview the process owners (as shown on the organization chart) to learn about their individual capabilities and adherence to the present system.
What are the benefits of MDSAP
- Avoid multiple days of onsite auditing by various regulatory agencies.
- Simple access to a variety of markets
- More cost-effective
- Reduce the amount of time and resources spent on investigating findings from multiple audits.
Stages of Certification
Role of Our Team
- Understanding your activities and preparing for certification,
- Determine the procedures that are required,
- The consultant will provide draft procedures and formats,
- Training on the Draft Quality Manual will be provided,
- Internal control auditing,
- Internal examination,
- Support during the external audit Assistance in resolving nonconformities,
We will respond to you within one working day.