Join Innovize and our Vice President of Quality, Mark Rutkiewicz at the BioMed Device show next week in Boston, April 18-19, 2018.
Find us at Booth # 736 on Wednesday & Thursday at the Boston Convention Center.
On Thursday at 2 PM, Mark Rutkiewicz will be speaking on how Innovize has been involved in the FDA-supported Case for Quality. Mark has helped mold and envision this maturity-based instead of compliance-based process for medical device companies.
Learn how Innovize took advantage of this new FDA Medical Device Discovery Appraisal Program (MDDAP) to:
- be removed from the FDA's routine inspection list
- streamline PMA submission & waived pre-approval inspection
- streamline site change submission with accelerated approval
- streamline 30-Day Change Notices, bundling multiple products and changes, with accelerated approval
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