Compliance with MDR/IVDR – Stämpfli MedTech Services to the rescue
Increase your efficiency while getting compliant with the new EU regulation.
Recently Swiss Medtech published its industry study 2018, confirming the continued growth of this robust sector. However, the study also highlighted some of the obstacles that medtech companies in Switzerland have to deal with. The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) play a key part. Meeting compliance deadlines is currently the biggest challenge for manufacturers, suppliers, and retailers.
Is your company affected as well? Stämpfli MedTech Services offers solutions in all critical areas, providing you with vital advantages in your struggle to become compliant with the new regulation.
Lack of internal resources
You don’t have the necessary internal resources for the timely implementation of MDR/IVDR projects? We can provide those resources to help you overcome deadline bottlenecks. Whether it’s consultants, project managers, or implementation specialists – thanks to our extensive experience in the industry we get up to speed fast and support you in resolving specific challenges and reaching important goals. We can work either in Bern or at your location integrated in your organization.
Comprehensive documentation requirements
The requirements for technical documentation have become more extensive, not just in regards to market admission, but also after market entry. Especially in the area of labeling we can help you with our comprehensive know-how along the entire process chain and support you with optimizations.
- Instructions for Use (IFU)
- Electronic Instructions for Use (eIFU)
- Package inserts
- Additional tech file elements
Whether it’s a single project or large-scale tech file remediation, a new design, or an update – our goal is always to provide you with added value.
Many medtech companies are not only concerned with MDR/IVDR, but consider digital transformation in general a necessary next step. According to these companies, action is required especially in the areas of production, distribution, data management, services, and customer interaction.
Is your company in the same position? We make your processes more efficient and increase your products’ range of coverage, for example in the following areas or using the following solutions:
- Product data management and maintenance using product information management (PIM)
- Catalog production (electronic or in print)
- Editorial system
- Digital asset management (DAM; structured management of documents and image data)
- E-Commerce (website, online shop)
- Online marketing (dialog marketing, social media, SEO and SEA)