Design & Development
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, IVD or drug-device combination 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, including AI-based medical devices. 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
- Implementing of a life cycle management for AI-based medical devices
- 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
Download
Download a wealth of knowledge here
Contact
Contact us
Get in touch with us free of charge to discuss your individual needs and find out more details about our services.
Your direct line to us
Let's work together to strengthen your competitive advantage, broaden your horizons and enter new markets. Click below to get in touch and take the first step.
NSF Prosystem GmbH
Beim Strohhause 17
20097 Hamburg
+49 40-668-788-199
