The orthopedic industry is one of the largest medical device markets. Our expert approach in global market authorization compliance has helped our clients make exceptional advancements in this area allowing end users to gain access to devices made with greater patient specificity.
At TW Consulting and Associates, we have experience moving companies from research using analyte specific reagents (ASRs) to IVD assays. Our regulatory project support assure GMP compliant ASRs and IVDs are internationally available to clinical labs and research facilities. De Novo filings of IVDs completed by our consultants result in swift market access in the US, Canada and EU markets.
Our expert consultants have successfully helped manufacturers of surgical drapes, surgical mesh products, drug-eluting stents, contact lenses, and other medical products to commercialize them on an international market. At TW Consulting and Associates, our expertise transcends throughout a broad range of product industries.
In addition to our premarket authorization support, TW Consulting and Associates focus on compliance requirements with harmonized IEC standards our clients must meet in the US and abroad.
Clients will engage us during product discovery and development to capture a multi-jurisdictional pathway for marketing novel medical products.
We offer services to local, state and federal agencies as well as international agencies. TW Consulting and Associates is committed to helping our clients introduce new medical discoveries that will improve healthcare.