Dental implant CE certification and ISO13485

I am currently leading the establishment of a dental implant company in Germany, structured as a GmbH. Our company will focus on the development, certification, and market introduction of high-quality dental implants, specifically targeting the Middle Eastern and African markets.

We are in the design and development phase and need expert assistance in the following areas:

Regulatory Consulting:
We require guidance on ensuring our dental implant system complies with EU MDR and FDA regulations. We are looking for experts with experience navigating these complex regulatory landscapes.

Quality Management Systems:
We need support in setting up and maintaining an ISO 13485-compliant Quality Management System, as well as ensuring compliance with the FDA’s Quality System Regulation.

Technical Documentation:
We seek assistance in preparing and reviewing technical documentation required for CE marking and FDA approval, including design dossiers, risk management files, and post-market surveillance plans.

Clinical Evaluation and Risk Management:
Expertise is needed to assist in preparing Clinical Evaluation Reports (CER) and conducting comprehensive risk assessments that meet both EU and U.S. regulatory standards.

FDA Submission Strategy:
We are looking for guidance on the specific regulatory pathways for FDA approval, including help with preparing submissions, clinical trial design, and risk management documentation.

Certificate of Origin for Export:
We need advice on obtaining a certificate of origin from Germany for exporting dental implants to the Middle East, Africa, Egypt, and Turkey. Since we aim to keep costs competitive, insights into the critical manufacturing steps that must be done in Germany to qualify for this certificate are essential.

We value thoroughness and detailed organization in our approach and seek partners who are committed to high standards in regulatory compliance and quality management. If you have the expertise in any of the areas mentioned, we would like to discuss how you can contribute to the successful launch of our dental implant system.

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