FDA Compliance Services to Medical Devices Companies

Our FDA compliance service enables you to get your products to the market quickly and helps you to maintain your FDA compliance status. Our FDA 510(k) Consultants have helped hundreds of companies to achieve and maintain their FDA compliance. Our product specific compliance service offerings are as follows:

Product Compliance

Product compliance or conformity is the certainty that the productmeets the necessary regulatory requirements to be available in the market. Medical device companies that bring their products to the market are under legal obligation to take the actions necessary to ensure that the products that they market is safe and effective and are following applicable local and federal regulations.

Our Product Compliance Services

For medical device manufacturers, product compliance is often the last step required before taking new products or technologies to the market. Regulatory Compliance support can be a long and complex process, but it does not have to be. Our FDA 510(k) Consultantare experts in providing you with regulatory guidance, testing services and compliance solutions to reduceyour company’s compliance burden and ease the path for regulatory approval.

Biocompatibility, Electrical Safety, Electromagnetic Compatibility (EMC)and Performance Testing Services

As one of the largest independent safety and effectiveness testing service provider, our FDA 510(k) Consultant provides Biocompatibility, Electrical Safety, EMC,and performance testing related consulting services to companies in the US. Our FDA Consultants have years of experience testing different kinds of medical devices for product safety and effectiveness for regulatory compliance. Our FDA Consultantsare medical device experts and routinely provide testing support for medical device companies and are approved by a variety of national and international accrediting bodies.

We serve companies of all sizes and product classifications within your budget. Please contact us for a quote for your submission