Medical devices are constantly evolving to provide new and improved types of treatment and diagnostics, relying heavily on technological and scientific advances. As opposed to other industries where manufacturers can self-declare product compliance, medical products often must be approved by national regulatory agencies such as US FDA and European Notified Bodies.
These agencies frequently increase their scrutiny and change their regulations to ensure the safety of the patients. Deep understanding of the regulatory requirements and procedures is critical to successful marketing of medical products.
At Hermon Laboratories, we partner with you from the definition stage, throughout development, testing and regulatory submissions, to help you reduce costs and reach the market more rapidly.
- ISO 13485 QMS Implementation
- Regulatory Strategy
- 510(k) Submissions
- CE Technical Files and Design Dossiers
- AMAR Registration