Quality & REgulatory Compliance
Quality Management System audits, implementation, gap analyses, improvement, and ongoing maintenance for compliance to:
European Union Medical Devices Regulation (EU MDR - 2017/745)
FDA Regulation (21 CFR 820, 21 CFR 1271, and related regulations)
All international medical device regulations and standards
American Association of Tissue Banks Standards of Tissue Banking
Medical Device Single Audit Program (MDSAP) requirements
Audit preparation and mock audits for audits under any regulatory jurisdiction.
Resolution of FDA Warning Letters, FDA 483s, Notified Body audit reports, or other regulatory authority findings.
Domestic and international field action (recalls) and adverse event reporting.
Administrative requirements for marketing (e.g. registration and listing).
Regulatory Strategy & SUbmissions
Worldwide regulatory strategy and submissions:
FDA submissions including Pre-sub, 510(k), PMA, and documentation for exempt products
Design dossiers, technical files, and medical device files for CE-marking under the EU MDD and EU MDR
Health Canada medical device applications
Australian TGA medical device applications
Other international marketing authorizations for both medical devices and human tissue
Clinical Evaluation Reports for compliance with MEDDEV 2.7/1, Rev. 4.
Creation and review of labeling and marketing materials for compliance and effectiveness.
Contract regulatory intelligence for up-to-date compliance and strategy.
General Consulting & Other Services
Product development and project management for a swift path to market.
Regulatory, quality, and technical due diligence for investments, mergers, and acquisitions.
In-house or remote training for:
Good Manufacturing Practices
Product Development & Design Controls
Quality Management Systems
Contract supplier management and auditing.
Regulatory assistance with import and export of components, finished medical devices, and human tissue for transplant.
Unique Device Identifier (UDI) implementation and listing with unique solutions for challenging products.
Consultation on selection and roll-out of electronic Quality Management Systems.
Consultation on manufacturing process qualification and design verification and validation.
Risk management for ISO 14971 compliance.