Approval of Medical DevicesWe support you in approving your medical devices! - Strategic advising and project management regarding approval of medical devices
- Communication with authorities and notified bodies
- Research of relevant requirements, legislation, standards, guidances
- Consulting on regulatory questions for the development of new devices
- CE-marking: Choice of an applicable conformity assessment procedure
- Classification of the medical device under the consideration of the intended use and the indications for use
- Creation of technical files according to the EC directives for medical devices 93/42/EEC with consideration of risk analysis, ergonomics and clinical evaluation
- Creation of the compliance checklist for the fulfillment of the essential requirements
- Review of the instruction for use and the labelling
- Creation of the declaration of conformity
- Moderation of the risk analysis
- Assistance for the fulfillment of the notification as medical device manufacturer
- Review of existing technical files
- Help desk for your questions
- Creation of a 510(k) dossier for product approval in the USA
- Research for the relevant FDA requirements
- Search for the essential US Agent
- Execution of the Small Business Registration in USA
Our products give you additional assistance for the approval of medical devices in USA and China.
Interested? Please contact us. |
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