Using compliance as a strategic competitive advantage
For the medtech industry, compliance with increasing regulatory requirements, such as ISO 13485 for medical device manufacturers, is of crucial importance and a key competitive factor – for global industry leaders and medium-sized companies alike. Implementing these guidelines not only minimizes legal risks but can also speed up go-to-market processes and increase the quality of products and services. Compliance requirements permeate the entire company – from the boardroom to logistics, production and quality departments through to IT, infrastructure and software tools. It is therefore important to efficiently combine the relevant guidelines and internal company requirements and ensure data integrity.
msg industry advisors support you in minimizing regulatory risks, establishing a forward-looking, risk-based quality management system and bringing your medical devices to market safely and in compliance with guidelines.
Safety through integration in quality & risk management
The holistic implementation of Medical Device Compliance can present companies with challenges. Medical products cover a broad spectrum, from consumables to laboratory equipment to implants, and are assigned to different product risk classes. To obtain certification and CE marking, it is necessary to fulfill and document the legal safety requirements. Digitalization is also becoming more important in regulatory terms, for example through digital health apps. This development brings with it new challenges for IT and IT security as a whole. Since the EU Medical Device Regulation (MDR), post-market surveillance has also come into effect, with an additional safety report for particularly strictly monitored products. This means that the long-term effects of the products must be monitored and documented throughout their entire life cycle.
Success Story Product Development
Getting Product Development back on track
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Our Capabilities
With extensive industry expertise in the medtech sector and in-depth experience in the implementation of regulatory guidelines, we support you in setting up integrated compliance – from certification to a suitable go-to-market strategy.
We help you determine the risk profile of your products and your company in regard to regulatory requirements and develop appropriate measures for implementation.
We are at your side when it comes to designing and setting up an appropriate QM system and integrating other departments and processes to ensure comprehensive Medical Device Compliance.
We support you in monitoring the quality, performance, and safety of particularly sensitive products over their entire life cycle by the guidelines and in setting up the corresponding documentation.
Minimizing product risks and increasing quality together
Contact our experts to jointly ensure the smooth and compliant market launch of medical devices and systematically increase product quality.