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Qmed Consulting is a consulting company offering services within clinical development and regulatory affairs for medical devices. We assist medical device companies and offer a range of contract research organization (CRO) services. Our goal is to provide the necessary documentation and assistance to the medical device companies bringing their products to the market expeditiously.
Qmed Consulting provides services in the following areas:
- Preclinical research services helping the company to identify, prepare and perform relevant animal test(s) in accordance with ISO 10993 and US GLP regulations
- Clinical research services from the formulation of a trial strategy to clinical trial document preparation, Project Management and Study monitoring in compliance with ISO 14155 and US FDA CFR 812.
- Regulatory affairs services developing the company regulatory strategy