Innovative Solutions to Your Challenges

Our Competences

The demands on medical device manufacturers are getting more and more complex.

Thanks to our vast experience gained over many years, we can support you in performing your tasks. We will gladly take over even entire spheres of activity from you to completely relieve you of these tasks so that you can concentrate on your other special assignments. This will ensure an effective workflow in your enterprise, and you will have enough time for the tasks requiring your core skills.

Due to our extensive practical experience, we are your competent partner in:

  • Quality Management & Quality assurance
  • Technical Documentation & Medical Device Approval
  • Medical Device Reporting & Medical Device Safety Officer
  • Audit Preparation, Support & Procedure
  • Risk Management & Usability Engineering
  • Product Development & Documentation
  • Clinical Research & Clinical Evaluation
  • Project Management & Project Documentation
  • Interim Management & Restructuring

Quality Management & Quality Assurance                           

You can benefit from our hands-on experience in the efficient implementation of the quality management requirements of

  • EN ISO 13485
  • 21CFR Part 820
  • Chinese FDA GMP (medical devices, sterile medical devices and implants CFDA overseas GMP audit)

We will also be happy to offer assistance in measures of feedback process optimization, completion of CAPA actions and implementation of change processes.


Technical Documentation & Medical Device Approval

With regard to the approval of your medical devices in Europe, we will provide you with integral support from selecting a notified body through to the preparation of technical documentation to clarifying queries of the notified body arising in the course of reviewing your documents. As to the approvals outside of Europe, our partners are there to help you, especially in the U.S. and in China.

Risk Analysis, Risk Management & Usability Engineering

We adhere to EN ISO 14971 in terms of risk management; we will also gladly carry out the PFMEAs for you. It goes without saying that we will provide you with the necessary support in all tasks from the implementation of an efficient risk management process to the preparation of the required proofs. You can also benefit from our experience and problem-solving skills in fulfilling the requirement from usability engineering as per DIN EN 62336-1:2017-07.


Product Development & Documentation

We make your product ideas come true

Do you have new product ideas or think of re-designing your existing devices? Thanks to our years of hands-on experience, we will make an ideal partner for you and offer you support ranging from the very first feasibility analysis right to the launch of series production. We can relieve you of the entire development process, or take over several selected parts of it. We will provide you with all development steps – from design input through to design outputs, design reviews, design verification and validation to design transfer, and that including documentation – in their entirety according to your specifications in the field of design control of your quality management system. You can also rely on our assistance in preparing design history files, technical documentation and/or device master records. We can just as well execute the entire range of these tasks for you. In our capacity as your development partner, we use the SOLIDWORKS 3D CAD system. As to optics simulation, we opt for ZEMAX.

Project Management & Project Documentation

Thanks to our many years of hands-on experience in the project management of all kinds of projects, starting from feasibility studies through to product development, product optimization, introduction of new technological methods, processes and aids to sales-oriented projects, we are your ideal partner as far as all these issues are concerned. We can, of course, assume responsibility for entire projects and inform you or your staff members about their progress and the results achieved at agreed intervals; and once the project has been completed, we will submit to you the project results together with the adequate project documentation. If you need support in any partial tasks of project management and project documentation – we are there to help.

Medical Device Reporting & Medical Device Safety Officer (Section 30 of the Medical Devices Act-MPG)

Together with our international partners, we have gained substantial experience in medical device reporting according to

  • 21CFR803
  • MEDDEV 1.12/1 rev.8
  • MPSV
  • Chinese FDA

Get us on board, and together we will create a medical device reporting process customized to your needs. Our expertise is also at your disposal for the implementation of this process. It goes without saying that you can assign the task of medical device reporting to us to a permitted extent. We have many years of experience in the function of Medical Device Safety Officer (Section 30 of the Medical Devices Act – MPG), and will be pleased to take this task over from you.

3D presentation of an intraocular lens (SolidWorks)

Optics simulation with ZEMAX

Clinical Research & Clinical Evaluation

Our experience in the field of clinical research and clinical evaluation of medical devices is primarily focused on ophthalmology. Let us be your partner for all matters of clinical evaluation of your devices – from preparation of clinical evaluation plans through to literature research and monitoring of clinical studies/trials with your products to preparation of clinical evaluation reports. You can benefit from our expertise in all matters of post-marketing follow-up as well.

Audit Preparation, Support & Procedure

You can benefit from our experience in audit preparation and support according to EN ISO 13485:2016, 21CFR§820 (U.S. FDA), China FDA as well as Korean FDA. Relieve your own teams of these tasks and assign them to us. You can rely on our support during auditing in the back office; we can, of course, arrange the back office organization for you. We can also assume the task of planning and execution of internal system audits as well as system audits at your suppliers’ including documentation.

Interim Management & Restructuring

We can look back on up to 20 years of management experience – from department management to top management of an entire enterprise. This experience is at your disposal for processing your tasks. On the one hand, we can temporarily assume management tasks in the event of staff shortages; on the other hand, we can create restructuring concepts together with you in order to optimize your results, and offer you support in implementing these according to your wishes.

Would you like to know more?