Successful approval of medical devices worldwide
In order to be able—and especially to be allowed—to successfully bring a medical device to market, it is essential to engage with regulatory requirements as early as the medical device development stage.It is vital to familiarize yourself with the requirements of target markets and country-specific particularities. Technical and regulatory requirements and conditions may differ substantially from those commonly recognized in Europe.
Despite the many efforts towards harmonization, considerable national differences remain and must be addressed early on. Overlooking such differences is one of the main reasons why regulatory approvals can be delayed for extended periods.
- Regulatory consulting for the approval of your medical devices outside the European market
- Extensive practical know-how from experienced professionals
- Quality management, registration support, and more
At en.co.tec, we assist you in obtaining worldwide approval for your medical devices—with individualized support, customized advice, and extensive experience, also on an international level. We offer support in quality management (MDSAP), medical device registration, risk management, and a wide range of other specialized topics, and provide you with all the information required.
We serve as your guides for a seamless registration process—together, we will successfully navigate complex international requirements
Our services for the approval of medical devices
Our offer:
With our experience in international medical device approvals, we help you save time by proactively sharing our expertise on country-specific requirements.
If you need support with international approval, we are happy to assist you!
Approval of medical devices in the USA
In summary, for European manufacturers of medical devices, the US market is usually the first international destination after the European single market. Successfully entering the US market is considered a strategically important milestone and a gateway to further international markets. Above all, due to the market volume and the particularly innovation-friendly environment, submitting an application to the FDA is especially attractive.
While you might currently face challenges finding a Notified Body in Europe, the FDA actually offers a Pre-Submission Program, allowing you to align expectations for your application ahead of time. Interesting? Please read on…
Approval of medical devices in Canada
The Canadian market, like all medical device markets, is growing dynamically and is especially interesting when combined with FDA approval in the USA (keyword: MDSAP). By the way, most medical devices in Canada are imported.
Since 2019, an MDSAP certificate (Medical Device Single Audit Program) has been a prerequisite for placing your product on the Canadian market. Health Canada distinguishes between the Medical Device License (MDL) and the Medical Device Establishment License (MDEL). The MDL only requires registration of the manufacturer and listing of the products. If your medical device requires an MDL from Health Canada, you must apply for product-specific approval; the process is comparable to the 510(k) procedure of the US FDA.
en.co.tec—your partner for successful medical device approval!
With en.co.tec, your company benefits from our long-standing service in the assessment and approval of diverse medical devices. We draw on our expertise in many areas of medical technology, as well as in various classes and risk factors, to provide you with optimal advice.
- Product classification
- Preparation for approval, e.g. FDA presubmission, gap analysis regarding required tests and missing clinical data, etc.
- Upgrade of the quality management system to FDA Quality System Regulation and/or MDSAP (Medical Device Single Audit Program)
- Compilation, review, and submission of applications.
- Communication with the regulatory authorities, FDA (USA) or Health Canada, throughout the entire approval process, including submission of additional information and documents during the review process.
Your needs and requirements are our top priority, and we create an individual and personalized plan to make the approval of your products as easy as possible for you. Bring this expertise and our comprehensive medical device services directly into your company!
Our training courses & events
Are you interested in medical device approval in general and want to gain knowledge on the subject yourself? In our training sessions and events, you will receive information and learn more about the requirements and how to skillfully implement them in your field.
Benefit from the practical knowledge and information provided by our experts—training sessions on the approval of your products can also be held at your company on-site or online. Get in touch – we look forward to hearing from you!
We have already had the opportunity to work with many companies and experts – here you will find an overview of our references:
Whether in Austria and Europe, the USA, or internationally – we support you in the successful approval of your products! Benefit from the expertise and services of the consultants at en.co.tec and get in touch with us.
Are you interested in expanding your knowledge and receiving information about medical devices in your field? Then take a look at our event calendar and book your place at one of our training sessions today.– We look forward to seeing you!
