FDA Device Submission & Medical Device Certification Capabilities »
- FDA device submissions including pre-submission requests, 510(k), De Novo, PMA, PDP, and IDE programs for FDA clearance or approval.
- Testing and certification to IEC 60601-1, 3rd edition, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- Safety and performance requirements defined by collateral (IEC 60601-1-X) and particular standards (IEC 60601-2-X) such as IEC 60601-1-11 for home healthcare equipment, IEC 60601-1-6 for usability, and IEC 60601-1-8 for alarms.
- IEC 60601-1 3rd Edition along with IEC 60601-1-2 4th Edition, both place an increased emphasis on risk management conforming to ISO 14971 and essential performance. We can assist you through this process and provide an assessment to ISO 14971 the Application of risk management to medical devices.
- Testing and certification to IEC 60601-1-2, 4th edition, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
- Have an active implantable device? MET can perform the testing and evaluation required by ISO 14708-1, Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer, and its parts.
Related Pages and Capabilities:
- Medical Device Testing & Certification
- Medical EMC Testing
- Medical RFID Suceptibility
- Wheelchair Testing
- Inspections of high-end medical equipment (e.g. MRI and CT scanners) in hospitals
- Medical Device Battery Safety Testing
- National Certification Body (NCB) & Certification Body Testing Laboratory (CBTL) testing & certification for Medical Electrical products.
- Complete testing for active implantable devices (ISO 14708)
Your Global Testing Partner for Notified Body Services and Global Approvals »
With 16 laboratories in North America, Europe and Asia Pacific, Eurofins offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs.
Our international presence ensures a unique global breadth of harmonized capabilities to solve all of your testing challenges and guide you through the complex regulatory landscape to help you develop the optimal strategy for your medical device testing needs.
Notified Body Services:
- Type Examination (Annex III): EC certificate showing conformity of the Medical Device examined (type) with the essential requirements established in the directive.
- EC Verification (Annex IV): EC certificate that guarantees and declares that the production batch (statistical verification) or each product (individual verification) conforms to the type certified and to the applicable requirements of the directive.
- EC Declaration of Conformity: Guarantee of quality of the manufacturing process or of the product (annexes V-VI), the certificate that guarantees and declares that the quality system, with regard to sterility, is applied and complies with the requirements of the directive.
Other Related Services:
- Chemical/Physical Analysis
- Microbiology & Sterility
- Packaging & Seal Integrity
- Combination Products
What is an FDA Medical Device Submission?
The FDA Medical Device Submission process is the series of steps that a manufacturer must take to obtain device approval for a medical device intended for sale in the United States. The process will vary for each device according to the device’s classification. Regulatory requirements are most strict for Class III devices, less strict for Class II devices, and least strict for Class I devices. Examples of the different type of device approvals include:
• FDA 510(k) Pre-market notification
• Premarket Approval (PMA)
• Investigational Device Exemption (IDE)
When will I need to submit an FDA Medical Device Approval?
Any product or device that is intended to be used for a medical application in the United States will require some type of FDA approval. The approval process will grow more complicated depending on your device’s classification and intended use application. Manufacturers will need to complete the applicable approval process, obtain a medical device listing, and meet all regulations for their product before the device can be sold in the United States.