HomeMedical Devices
Instrumental in the success of your medical devices
Medical devices form a broad category of products, including heart valves, hip implants, syringes, lab diagnostic equipment and contraceptives. We provide a full range of services required to enter and grow in the US and Canadian marketplaces, from device classification to registration, and from compliance planning and regulatory liaison to label review.
Services for the United States
- Regulatory planning and product classification
- Liaison with regulators during development, submission and approval
- Liaison with regulatory agencies on regulatory, CMC, clinical and toxicology matters
- Responses to regulatory agency questions
- Expert regulatory CMC compliance advice throughout development
- Expert consulting on FDA 510(k) clearance submission, including documentation for review
- Review of testing requirements, compliance to FDA guidance documents and standards
- Provision of a detailed list of documents, reports, diagrams or clinical data needed before 510(k) preparation can begin
- Preparation of a technical comparison of your medical device to other predicate devices with FDA 510(k) clearance
- Medical Device Reporting
- Label review for compliance with 21 CFR part 801
Services for Canada
- Regulatory strategic planning and product classification
- Organizing and managing meetings with Therapeutic Products Directorate (TPD)
- Preparation and filing of CTA’s (Clinical Trial Applications)
- Preparation and filing of Class II, III and IV applications
- Application support during TPD review
- Quality System audits
- Label and advertising review
- Resolution of regulatory compliance issues