VYSYO is your partner in the development, market accesss and approval of medical products VYSYO is your partner in the development, market accesss and approval of medical products VYSYO is your partner in the development, market accesss and approval of medical products

Complex regulatory requirements worldwide demand proof of safety and performance of medical devices based on clinical data. Health authorities are increasingly critical in evaluating your products and quality assurance.

Benefit from our clinical expertise and increase
your chances of success in a complex market.

Complex regulatory requirements worldwide demand proof of safety and performance of medical devices based on clinical data. Health authorities are increasingly critical in evaluating your products and quality assurance.

Benefit from our clinical expertise and increase your chances of success in a complex market.

CLINICAL EVIDENCE

CLINICAL EVALUATION, PLANNING & POST-MARKET STUDIES

The requirements for clinical evidence for the safety and performance of medical devices are increasing worldwide.

This leads to a growing demand for Clinical data that must be collected – with the help of studies.

In the future, we expect that more CLINICAL DATA will be used within the framework of evidence-based medicine to check the reimbursability of your products by health insurers.

We have experience with all aspects of the market: the physician’s, the user’s, the health insurer’s, the manufacturer’s (also OEM) the importer’s, the authorized representative’s and the distributor’s. Benefit from our experience with clinical data and clinical trials.

Actively collect your clinical data!

WE ARE HAPPY TO SUPPORT YOU

  • In the preparation of your clinical evaluation.
  • In proving the performance of your products so that you can increase your market advantage in the future.
  • In reconciling clinical data with your risk file, usability and other information.
  • In planning and conducting clinical trials.
  • In post-market studies.

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REGULATORY REQUIREMENTS

We support you with international approvals worldwide,
in accordance with the applicable country-specific regulatory requirements.

Regulatory requirements vary greatly depending on the region and the medical device. One thing they have in common is the need for structured documentation of evidence of regulatory compliance. The focus is on the safety and performance of medical devices. We support you in reviewing and creating your technical documentation.

REGULATORY STRATEGY

In this process, we work with you to develop the most favorable regulatory strategy for you:

 

  • Determination of classification
  • Communication with authorities (e.g. organization and participation in FDA pre-submission meetings)
  • Elaboration of the clinical strategy
  • Selection of the regulatory process
  • Determination of the necessary submission documents

APPROVAL

We prepare the approval dossier with you:

 

  • Selection of test laboratories and support of product testing.
  • Support in conducting clinical studies in the respective country
  • Compilation of the registration dossier, if necessary also update of your technical documentation
  • Translation of the documentation

LET’S WORK TOGETHER!

3 + 14 =

QUALITY MANAGEMENT

Among many other things, manufacturers of medical devices are required by law to establish and maintain a quality management system (QMS). For all medical devices, with the exception of devices with comparatively low risk potential (Class I), the manufacturer is required to have his QMS audited and certified by a notified body before placing it on the market.

As a European manufacturer, your quality management system must meet the requirements of the ISO 13485 standard. Depending on the country in which you distribute your products  there are specific additional requirements.

WE ARE HAPPY TO HELP YOU

  • Implement the requirements of the quality management system.
  • To create process instructions that really fit your company and are applicable.
  • Execute the requirements of other countries in such a way that your system remains clear and simple.

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TECHNICAL DOCUMENTATION

Every medical device requires documentation from which the evaluation of conformity with the applicable requirements is possible.

The technical documentation (TD) consists of many elements that must comply with various requirements and international regulations.

Experience shows that it is often complex to keep this data up to date.

For this purpose, we have developed a system that helps you avoid errors and keep your files clear.

We support you in checking and creating your technical documentation.

WE ARE HAPPY TO SUPPORT YOU

  • Implement a system for archiving your documents.
  • Keep your technical documentation in accordance with various country-specific requirements.
  • Create clear assignments of versions to product groups and serial numbers.
  • Carry out product changes efficiently and legally.
  • Execute the requirements of other countries in such a way that your documentation system remains clear and simple.

CAREER OPPORTUNITIES

At VYSYO, we are looking for entrepreneurial employees who are passionate about their work. Determination, integrity and willingness to learn characterize you just as much as an interest in new things.

If you are interested in working for us, please send us your inquiry and / or your application documents with salary requirements.

We are looking forward to your application!

CONTACT

VYSYO GmbH

Invalidenstraße 36 · D-52249 Eschweiler · Germany

Phone +49 2403 7578920 · www.vysyo.com · info@vysyo.com