Do you want to obtain market authorizations for your products ? Do you want to create or expand your product line and adapt them for new markets ?
We can help you in the life cycle of your products by :
- Supporting you in the technical development of new products and associated services,
- Defining regulatory requirements applying to new products or new markets,
- Evaluating the need to certify or recertify your products,
- Building and updating CE marking technical files,
- Building and updating your 510(k), DMR and DHF files for the FDA,
- Preparing for CE certification audits, and FDA inspections.
You can rely on our expertise in new technologies (medical devices, software), registrations (CE marking, FDA) and certification (ISO 13485) to accelerate the marketing of your products.
We can also help you in the management of Regulatory Affairs by :
- Carrying out regulatory monitoring: we offer quarterly regulatory monitoring.
- Maintaining technical files (CE marking) and DHF, DMR, DHR (FDA),
- Assisting you in initial audits, monitoring and renewal of CE certification and FDA inspections,
- Managing regulatory affairs specific to new markets,
- Acting as Person Responsible for Ensuring Compliance with Regulations (PCVRR).
MD101 has supported more than 600 customers in compiling the technical CE marking file for their devices. Our team has experience working on medical devices of all classes (I to III) and of all types : non-active, active implantable, software, handsets, etc.
MD101 offers a quarterly regulatory and standards monitoring service for economic operators and manufacturers of medical devices.
At the border of quality assurance and regulatory requirements, the Medical Device Single Audit Program (MDSAP) is a program set up under the aegis of an international body.
MD101 can support you in this compliance process.
Once CE marking or FDA clearance has been obtained, it is possible to register your device in many countries thanks to an accelerated procedure.
We can support you by taking care of the registration of your devices in all regions of the world thanks to our network of partners.
As a manufacturer or representative of a manufacturer outside the European Union, you must have a person responsible for verifying compliance with the regulations (PCVRR), according to the requirements of article 15 of regulations 2017/745/EU and 2017/746/EU.
We can support you in this process.
Post-market monitoring is a requirement that was present in the directive and which has been reinforced and clarified in the Medical Device Regulation in Article 83 of Regulation 2017/745/EU and Article 78 of Regulation 2017/746/EU.
We can assist you for this crucial step.
Our approach is to support you with our partners based on the American market. Our partners manage the relationship closely with the FDA and define the regulatory strategy. MD101 experts work with you to draft the documents required for the FDA : description of the product for a pre-submission meeting or for a 513g, drafting of the documents required for a 510k, a de Novo or a PMA.
We are your partner to help you bring your device to market faster in the US.