Together with our partner Integrated Device Solutions (IDS), we had the opportunity to assist a medical device manufacturer during the development phase of a Class III product—with the dash of excitement that only insulator production can provide.  

What we had on our radar:   

✔️Regulatory GAP analysis, so no one asks questions during the audit 

✔️Making development and production processes compliant with ISO 13485 and GMP (including medium WFI)   

✔️Ensuring regulatory compliance – so the regulatory authority can check the box with a clear conscience. ✔️ 

✔️GMP requirements and medtech regulations – how they mesh perfectly 

Through structured analysis and targeted process optimization, we were able to help our clients   

👉 minimize regulatory risks early on – so the regulatory authority can check the box with a clear conscience.” ✔️ 

👉Create transparency in development and production—you can really see what’s happening  

👉 Make the path to market readiness significantly more efficient—time is money, but regulation is more important 

Especially with Class III products, it’s crucial not to just “think about” regulatory requirements, but to strategically integrate them into development from the very beginning, following the Quality-by-Design philosophy. 

Interested in our combined expertise in GMP, medtech regulations, and process know-how? Let’s talk. 📞 

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