Design & Development

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Consulting

Design & development

Is your design and development process too complicated, hindering product realization instead of promoting it?

Does you often lose track of traceability, and do your design inputs rarely match the hoped-for design outputs?

Only an optimized product realization saves valuable resources and brings your product quickly to the market.
Benefit from our experience and get in touch with us. We are here to help.

Support

Timely and targeted product realization

Product realization according to ISO 13485 and 21 CFR Part 820.30 is a documented method that ensures that what you believe you are developing is also what you wanted to develop from the beginning. This ensures that your medical device or IVD is exactly what your customer needs and what your company is allowed to market and distribute.

Our team of experts supports you in developing products that meet regulatory and normative requirements as well as the latest state of the art.  We help your company ensure that specifications and requirements from product definitions are met and process interfaces are coordinated so that cross-departmental cooperation in product realization works.

Shorten your valuable time to market with our expertise and develop the right product for your target market.

Services

Our consulting services for you!

  • Development of product realization according to ISO 13485 and 21 CFR Part 820.30
  • Creation and optimization of processes and plans for product development
  • Improvement and support in requirements management
  • Implementation of a software lifecycle process according to IEC 62304 and IEC 82304-1
  • Development of risk management according to ISO 14971 and cybersecurity according to IEC 81001-5-1
  • Integration of biological evaluations according to ISO 10993-1 into risk management
  • Creation of the Device Master Record (DMR) and Design History File (DHF)
  • Support with design and process changes
  • Evaluation and auditing of suppliers
  • Training at your location or in our academy in Hamburg

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News

Always up to date

The EU Commission has updated the timelines for the EUDAMED modules. A significant milestone is the announcement of the finalization in the EU…

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AI systems in medical devices introduce a new set of risks and  performance parameters. Without a lifecycle for each model, manufacturers cannot…

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Mark your calendars! Next year, we are excited to offer the NSF Summer Camp - Intensive Course for Regulatory Affairs Managers once again. The…

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Get in touch with us free of charge to discuss your individual needs and find out more details about our services.

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NSF Prosystem GmbH
Beim Strohhause 17
20097 Hamburg

+49 40-668-788-100

+49 40-668-788-199

info-medicaldevices@nsf.org