Regulatory Affairs Consulting
You are here:
Home >
What we can do>
Regulatory and Quality>Regulatory Affairs Consulting
Service offerings for Regulatory Affairs Consulting include:
- Strategic planning
- Project Management
- US Regulatory submissions to FDA (export approvals, pre-IDEs, IDEs, 510(k)s and PMAs for all classes of medical devices)
- FDA meetings (introductions of company and device, regulatory & clinical strategies, test plans)
- ISO Certification and CE Marking (OUS Regulatory submissions include Technical Files, Design Dossiers, Clinical Evaluation Reports)
- Notified Body meetings (interviews/hiring/contracts)
- Regulatory input on test requirements/plans, external standards, essential requirements, predicate device comparisons
- Internal audits, including GLP animal lab audits
- Mock FDA and Notified Body Audits
- On-site Regulatory support during FDA and Notified Body inspections
- Management of product recalls, safety alerts, market withdrawals
- Decision making on reportable changes to regulatory agencies
- Daily operational regulatory guidance and support (Acting Regulatory VP role for companies)
- Animal study design and scribe during studies
- Regulatory representative in due diligence discussions for acquisitions and mergers
- Design, Development and Implementation of Quality Management System (Quality System Regulation and ISO 13485)
- Development, implementation and maintenance of Document Control Systems
- ISO Certification and CE Marking
- Quality System training
- Internal audits and audit program implementation
- Design History Files
- Management Representative
- Notified Body and FDA Liaison
- Facility Registration and Device Listing
- Review of labeling and advertising materials
Get started today by contacting Innoventz.
Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.
