Regulatory Affairs (approval)

From regulatory strategy to successful market approval and maintenance of your medical devices

Depending on the country where the medical device is to be marketed in, companies have to fulfill different regulations such as the European Medical Device Regulation (EUMDR) for European countries or for the US market FDA Code of Federal Regulations (CFR) 21.

For the European market, the creation and maintenance of technical documentation must comply with the requirements of the European Medical Device Regulation (EUMDR) and other CE directives. For the US market, manufacturers have to adhere to the Code of Federal Regulations (CFR) 21 for the different FDA submission pathways such as  510(k) (21 CFR 807) , PMA (21 CFR. 814.42) or De Novo 513(f)(2). Companies are also advised to participate in a Medical Device Single Audit Program (MDSAP). The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Successful approval of a medical device from the FDA or an European Notified Body includes risk analysis, risk assessment, and clinical evaluation to demonstrate performance and efficacy. Moreover, each company needs a comprehensive Quality Management System (QMS) based on ISO 13485 and the Code of Federal Regulations (CFR) Title 21, Subchapter H, Part 820, Quality System Regulation.

Likewise, it is important to establish an efficient regulatory strategy. This includes the determination of the FDA classification of the medical device, identification of regulatory opportunities and limitations and their connection to the proposed intended use, the classification of the product based on the selected regulatory systems, the consideration of applicable laws and standards, the listing of additional regulatory requirements such as a QMS, the determination of the registration sequence for different countries, and, overall, the review of the regulatory pathway (510 (k), PMA, DeNovo in consultation with the Notified Body or the FDA.

Pharma Expertise Consulting supports you throughout the FDA submission process/ the EU CE Marking process  from the selection of a qualified and reliable Notified Body to the entire approval process with a National Competent Authority (NCA) or the FDA.

Once an approval concept is established, we assist you in setting up a documentation architecture, listing and prototyping the required documents, updating the risk management file, organizing the design control and V&V support documentation, organizing process controls (including supplier audits), conducting clinical trials and preparing clinical evaluation reports, and implementing a QMS compliant with Quality System Regulation QSR persuant with ISO 13485:2016 and the CFR 21, Subchapter H, Part 820, Quality Sytsem Regulation.

Pharma Expertise Consulting ensures monitoring, compliance, and maintenance of medical devices and in vitro diagnostics throughout the entire product life cycle.

Do you need support in medical device regulatory affairs? Feel free to contact us!