Certification of Medical Equipment

Do you require certification for medical equipment? Need professional assistance as well? Then you’ve come to the right place!

Our law firm has been operating in the legal services sector for over ten years. Our professionals have perfected the mechanisms for handling cases of any complexity and time constraints, ensuring the certification process meets all legislative requirements.

We are fully committed to supporting the medical field and improving patient care standards. Hence, certifying medical products and equipment is our way of proving this not just in words, but in actions.

How can we assist in the certification of medical equipment?

• Consultancy based on the client’s requirements and goals, as we develop an optimal action plan.
• Certification’s application submission along with the complete set of accompanying documentation.
• Preparation and Submission of Samples for all necessary examinations.
• Conducting Necessary Tests– both on the products and the entire production process.
• Issuance of the certificate of conformity to the client, guaranteeing the product’s quality and safety.

How long does the certification of medical equipment take?

The certification of medical equipment takes up from 20 days.

List of documents required for the certification of medical equipment:

• A copy of the document confirming the authority of the manufacturer’s authorized representative.
• Information on the regulatory documentation for the medical device.
• Technical documentation for the medical device.
• Operating documentation for the medical device, including the instructions for its use or the user manual.
• A photographic image of the general view of the medical device along with the accessories necessary for its intended use (minimum size 18 x 24 cm).
• Documents confirming the results of the medical device’s technical tests.
• Documents confirming the results of the medical device’s toxicological studies, if it involves contact with the human body.
• Documents confirming the results of the medical device’s tests for the purpose of measuring instruments type’s approval.
• An inventory of documents.

If you have not found the necessary information regarding your question on our website, or if you have any questions, you can always contact us through the methods presented on our contact page.