Regulatory Affairs

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Consulting

Regulatory affairs

Has a specialist or senior manager left your team, leaving a gap that threatens projects?

You have been warned by the authorities and now need to act quickly - but how to go about it?

Is it unclear from your market analysis which regulatory requirements the product actually needs to meet?

Only a strong team with a clear understanding can hold its own in the market in the long term.
Benefit from our experience and contact us. We are here to help.
 

Managment

Interim and crisis management

People at the top of a company make the decisive difference - especially in exceptional business cases. Our interim and crisis management offers high-quality solutions for medical technology and pharmaceutical companies that are in a phase of significant change. We support you in getting your company back on the path to success.

We are not only able to introduce you to suitable experts, but also to provide technical support throughout the entire deployment. Our consultant has access to an entire team of experts in different fields at NSF. This ensures the successful implementation of the project and offers your company an additional level of quality assurance.

Support

Registration strategies

Our regulatory affairs department develops the simplest and strategically most efficient way to approve your medical products in the four major market regions EMEA, NAM, LATAM, and APAC.

Our experts have many years of experience in local market authorization processes and will advise you on all regulatory issues to classify your products in the right product category and to define the regulatory and normative framework. Our services support you throughout the entire product lifecycle.

Services

Our consulting services for you!

  • Determination of corrections, corrective or preventive actions (C/CA/PA)
  • Correspondence with authorities and notified bodies
  • Interim management for QA/QM/RA positions
  • Planing, implementation and maintenance of quality management systems
  • Registration and listing of medical devices and IVDs
  • Taking over and managing development projects
  • Restructuring of processes and departments
  • Expert opinions and statements on product demarcations
  • Building approval strategies for all important markets such as the EU, USA, China, Japan, South Korea, Australia, Canada, Brazil, etc.
  • Determination of applicable standards and legal requirements for compliance with product safety and the state of the art
  • 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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Contact

Contact us

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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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 40-668-788-100

+49 40-668-788-199

info-medicaldevices@nsf.org