Medical Device Manufacturing
We’ve been helping customers to master growing regulatory requirements through paperless manufacturing for more than 25 years!
Paperless manufacturing for the medical device industry
The medical device industry, which is dominated by small and medium-sized companies in Germany, is a global success model with its innovative strengths. The predicted increase in demand of innovative medical devices offers further above-average growth potential.
A huge challenge for medical device manufacturers is the constant increase of regulatory requirements for the authorization and sales of medtech devices, for example with the EU-Medical Device Regulation (MDR). These regulatory requirements lead to delays in innovation and imply a considerable cost factor. In addition, complex supply chains and the growing number of product variants are increasing the pressure to digitalize manufacturing processes for paperless manufacturing.
Modern solution platforms that integrate all processes from design to engineering, planning and manufacturing - including ongoing documentation (eDHF + eDMR + eDHR) - up to an analysis, facilitate such a digital transformation. They reduce the use of paper and formats such as Word, Excel and PDF by up to 90 percent and enable Smart Manufacturing and Closed Loop Manufacturing.
We support our global customers in the medical device industry for more than 25 years with digitalizing, optimizing and automating their manufacturing processes. Initiatives such as Industry 4.0 provided a unique opportunity for our experts to contribute their know-how in manufacturing IT and shop floor integration for the implementation of industry standards.
Trends and challenges in medical device manufacturing
Current trends and challenges offer medtech companies a great opportunity to defend and strengthen their own market position or to expand their market leadership through a holistic digitalization strategy.
- Increasing regulatory requirements according to MDR, FDA
- More complex approval and distribution of products
- Product and (e)DHR must be perfect
- Rapid market introduction (NPI | New Product Introduction)
- Effective Non Conformance-Management including Reporting (NCR)
- Digital Thread PLM, ALM, MES
- Customized mass production of complex products
- Cost and efficiency pressure from design to manufacturing
- Increased flexibility of production
- DHF eDHF
- DMR eDMR
- DHR eDHR
- self-auditing eDHR
- Operator guidance
- Digital twin of product
- Digital twin of production
- Digital Enterprise
= ERP + PLM + MES
- Continuous, bidirectional real-time data exchange between development, planning and production
- Digital Thread to continually optimize production