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News from the world of medical devices

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EU - Updated list of planned MGCG guidance documents

The EU has published an updated list of MDCG guidance documents currently under development on the MDCG webpages. The list includes more than 40 entries concerning planned new guidances and updates to existing ones that are planned to be published in 2024.

EU – Update of the lists of harmonised standards for MDR and IVDR

The EU published two implementing decisions expanding the list of harmonised standards for MDR and IVDR. The decisions add 8 standards for MDR (25 in total) and 3 for IVDR (13 in total). The newly added standards address aspects of biological evaluation, processing (both for MDR), radiation sterilization and sterile packaging (MDR and IVDR). Consolidated summary lists of harmonised standards can be found on the respective EU websites for MDR and IVDR.

EU – New MDCG guidance document on content of the clinical investigation plan for medical devices

The MDCG published a new guidance document (MDCG 2024-3) that details the requirements for the content of the clinical investigation plan that must be included in the application for clinical investigations for medical devices. Aside from a description of required contents, the document gives a template for the clinical investigation study plan synopsis in Annex A that is available as Word document.

EU –Judgement of the EU court of justice with respect to access to harmonised standards

In a judgement from March 5 (C-588/21 P) the European Court of Justice confirmed its position that harmonised standards form a part of EU law. Consequently, the court ruled that there is an overriding public interest justifying the disclosure of harmonised standards in accordance with applicable EU rules for transparency. The Court did not explicitly address questions of copyright protection. It remains open how far reaching the right of access is and how access should be realised.

USA - FDA issues “final rule“ to amend 21 CFR 820

The FDA has issued a „final rule“ that implements the annouced amendment of 21 CFR 820 (and 21 CFR 4 for combination products) to harmonize the requirements for quality management systems for medical devices with ISO 13485:2016. Formal publication date is 2024-02-02, the rule will be effective 2026-02-02.

Medical device manufacturers

A fresh perspective can pave the way for amazing forces of change. We will work hand-in-hand with your team, bringing our expertise, enthusiasm and up-to-date knowledge to your business. Are you experiencing resource bottlenecks in your projects?
We can support you, for instance, in the further development of your QM system, during audits or when creating a technical documentation.


Have you set up your own business with a product idea? Are you on fire for your innovation - but unsure how to meet all the legal and regulatory requirements? Thanks to many years of experience in the medical device industry, we know exactly what is important now. Take advantage of our expertise surrounding development and manufacturing. So that you can concentrate fully on your core competence.

Research facilities

We support research groups in the life sciences sector, helping them to get their research results out into the world – for instance, when developing innovative materials, coatings or new diagnostic methods. When doing so, we always keep the regulatory requirements in mind, which ensures that your research results are always usable.

Our 4-point plan
for your success

Our interdisciplinary team of scientists and engineers, lead auditors and an occupational safety specialist look forward to sharing their expertise with you. Benefit from our professional services, tailor-made training opportunities, and established network of experienced specialists.



regarding the development, manufacture and authorisation of the products: We show you paths and procedures that will help you reach your goal without any detours.



of your projects: Our experts complement your existing resources and work together with your team to implement projects.



for your staff: Get your teams ready for their work with tailor-made in-house seminars and workshops.



for long-term success using your quality management system: We support you with training opportunities on the latest topics, during internal audits, during supplier qualification and when continually developing your processes.

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Highlights from our seminars

Basic seminar on medical devices

This seminar covers the basics of medical devices that previously fell within the remit of EC Directives 93/42/EEC and 90/385/EEC and now fall under the remit of European Regulation (EU) 2017/745. It is intended to provide an insight into the most important areas within the legal requirements for medical devices in Europe and establish a link to practical work.


Medical device consultant as per Section 83 of the German Medical Device Law Implementation Act (MPDG)

In accordance with the German Medical Devices Act (MPG), medical device manufacturers are obligated to ensure that medical device consultants and safety officers as per Sections 30 and 31 of the MPG have completed a sufficient level of training. This seminar is intended to provide employees in these roles with the knowledge they need to confidently work with the MPG and to explain their tasks a...

Basic seminar on risk management – Module 1

At the heart of the legal requirements for medical devices in Europe are the fundamental safety and performance requirements (previously known as essential requirements) that must be met by all medical devices. As a basis, they require a risk management system that covers all phases of the product life cycle to be implemented by the company. The prospective identific...