Safe. Effective. Reliable. Ready.

Companies invest millions in time, talent, and testing turning technology into products, then thousands MORE to fix product problems that crop up before, during and after launch:  

• A medical device receives a regulatory warning letters. That’s a problem. 

• A new product needs a redesign months after initial launch. That’s a problem.

• If that product is already committed to manufacturing, that’s another problem. 

• If that product is intended for integration into your customer’s products, that’s a BIG problem.   

Your team are experts in your core technologies, we are experts in product development.

We provide the ‘paperwork’ supporting successful commercialization, and growth.

Fixing product problems means reworking designs when budgets and timelines are tight. Success requires planning, skills, and experience to make the most of the product development process. We provide specialized skills and experience to develop products that are safe, effective, reliable, and ready. 

Saegert Solutions include:

• Medical Device Risk Management files that are:

  • Compliant to ISO14971:2019

  • Integrate Medical Device Design Controls and Risk Controls

  • Support regulatory requirements

    • Post Market Surveillance Plan / Report

    • Clinical Evaluation Plan / Report

    • Post-Market Clinical Follow-up Planning / Reporting

    • Post-Market Safety Update Reporting

• Medical Device Design History File (DHF) Creation and Remediation

Medical devices are not our sole focus: the tools and techniques for successful medical device development apply to commercializing technology in ANY industry. How can we help you?

Investments in product development time, talent, and testing don’t pay for finished products – they pay for answers. 

Are you asking the right questions?  In the right order? Our strategies and experience capture your knowledge with structure and context to maximize its value. 

Guides, standards, templates, and software look easy to use, but often result in wasted work.  Even trained teams struggle, arguing about ‘what’ to information to record, and ‘how’ and ‘why’ to do it. 

Experience has taught us not only ‘what’ to do, but ‘how’ and ‘why’ to do it. 

We document your knowledge, develop your plans, and deliver results.

You’ll be more efficient, and self sufficient, developing your products with clarity and confidence.