Qserve America provides expert consulting services in the areas of regulatory strategic planning, regulatory submissions, and quality management systems to Medical Device companies worldwide.
Qserve America was founded in early 2005 and has experienced rapid growth since its inception with a number of successful device submissions cleared by FDA. A member of the Qserve Group BV, Qserve America is an independent consulting firm with the expertise needed to rapidly bring medical devices to the US market and elsewhere.
As a member of the Qserve Group, which includes experts in the EU Medical Devices Directives, biocompatibility testing, CE Marking, etc., Qserve America is uniquely qualified and positioned to help companies achieve market approvals on a dual path for both the US and the European Union (EU). By working on both submission strategies, redundant effort is eliminated resulting in faster product approvals in both major markets. This translates to a faster and larger market launch and more revenue for the client.
As a result of this combination, one of Qserve’s strengths lies in our unique combination of in-house expertise in a variety of regulatory and quality systems for medical devices such as:
- USA: FDA: 510(k), IDE and PMA submissions
- EU: CE Marking submissions
- Canadian (MDR) medical device registrations and CMDCAS
- Biocompatibility studies, pre-clinical studies
- Quality Management Systems, ISO 13485 and auditing
- Validations: product & process, IQ, OQ, PQ, PPQ
- US Agent & Official Correspondent
Our modular turnkey service packages enable you to select the regulatory, clinical and quality programs that best meet your specific requirements. This flexibility of approach makes Qserve highly adaptable to your unique objectives and needs.
Qserve, your one-stop-shop for all your regulatory solutions.
