Medical Device Consulting Services for US FDA

We can assist with everything, from US FDA Quality System Regulation (QSR) compliance and audits through to 510(k) preparation and Pre Market Approval (PMA).

Alongside advising on registration requirements for medical device categories (Class I to Class III) we can assist with all related quality system compliance requirements and the implementation of required post marketing surveillance systems (21 CFR Part 803).

When it comes to FDA liaison, our consultants interact daily with the FDA Center for Device and Radiologic Health (CDRH). Experienced and adept at using planned pre-submission meetings with the FDA to establish clear criteria for approval, our teams are expert at assembling submissions that demonstrate compliance with market approval requirements. These planning and preparation steps ensure our clients avoid costly delays and can respond effectively to any FDA questions that arise.

Provisional FDA Services by Authorized FDA specialist:

  • Specific regulation strategy reports
  • FDA GMP consultancy for Quality System Implementation
  • Designated regulatory agent in the US
  • Manufacturer Registration and Medical Device Listing

Premarket Notifications [510(k)]

  • Predicate device research
  • Assist with writing/assembling the 510(k) Indications for Use
  • Device descriptions
  • Summary and conclusions of pre-clinical and clinical studies
  • Proposed labelling/User Manuals etc
  • Filing and tracking of 510(k) through clearance

Premarket Approval (PMA)

  • Organize project team
  • Investigational Device Exemption (IDE) application/tracking
  • Assist with writing/assembly of PMA Indications for use
  • Device description
  • Alternative practices and procedures
  • Marketing history
  • Summary and conclusions of pre-clinical and clinical studies
  • Proposed labelling