Regulatory Affairs

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Regulatory Affairs

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North America - Medical Device Approval worldwide

Approval of Medical Devices by the FDA and Health Canada

The US-American FDA has the reputation to be the strictest authority for Medical Devices and the required on-site inspections are often feared. We are happy to help; we will show you what mistakes the inspectors are looking for, and that these FDA inspectors are not to be feared.

North America - Medical Device Approval worldwide

Approval of Medical Devices by the FDA and Health Canada

The US-American FDA has the reputation to be one of the strictest authorities for Medical Devices and the required on-site inspections are often feared. We are happy to help; we will show you what deficiencies the inspectors are looking for, and that these FDA inspectors are not to be feared.

Table of contents: Approval North America
  1. Challenges in FDA Medical Device Approval
  2. qtec as your partner
  3. Serious case of an inspection
  4. Canadian Medical Device Approval

Challenges with the FDA registration for Medical Devices- Sound familiar?

You are looking to conquer the US-American market with your innovative Medical Device, but you are hesitant because of the well known dreary, long and costly process that is associated with the FDA?

An inspection by the FDA is imminent and you are afraid of any discrepancies because they involve high costs?

Or you have already received a warning letter and are now aware that you cannot make any more mistakes?

The FDA presents the European manufacturers with many challenges:

  • High requirements on software, cybersecurity and biocompatibility
  • There are often new guidelines that must be followed
  • Apparent arbitrariness and unjustifiable rigor in decisions by inspectors and reviewers
  • Tough and expensive consequences in case of nonconformities right up to bans on imports

qtec as your partner

Choosing the right procedure for the market introduction of Medical Devices in the USA has a significant influence on the effort you will have to make. Regardless of whether

  • De Novo,
  • 510(k) or
  • PMA

we have successfully supported many market introduction with the FDA, and we are confident that we will be just as successful and cost/time efficient with your Medical Device.

But the 510(k) clearance or the PMA alone is not enough. We will implement a Quality Management System that is compliant with 21 CFR Part 820 and will not provide a target for attacks. Our experts know from long-term experience, what FDA inspectors expect.

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Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval and registration of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60
 

How we can help in case of an emergency inspection:

Regardless of whether in the front office or the back office we will manage the follow-up, and eliminate identified nonconformity reports which are recorded by the daunting form 483.

Additionally, our support extends as far as the processing of deviations that were not discovered during an inspection and arrive in the form of a warning letter.

Approval of Medical Devices in Canada

Incidentally, we also have experts for Approval with the "small" North American neighbor Canada. Whether you are planning your initial market access and do not yet have MDSAP certification, or have problems with the new Approval of products via the Licence Applications or Licence Amendments for Class II to IV: our experts will support you.

Examples of our supportive services:

  • classification of your Medical Device under Canadian law
  • setting up an ISO 13485 and MDSAP compliant QM System
  • obtaining the Medical Device Establishment License (MDEL) or the Canadian Medical Device License (MDL) for your Class II to IV products
  • Creation of the Premarket Review Document