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)

  • ISO 13485:2016

  • 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

  • Regulatory Compliance

  • Risk Management

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.