Regulation of Medical Devices

Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. SCC as a service provider has been monitoring the recent developments to offer you expert advice tailored to your needs and help you prepare the required approval documents. We support both, newcomers and established companies, paying special attention to the implementation of the relevant requirements, which we have outlined for you below.

Technical Documentation

A comprehensive technical documentation in accordance with the required country specific regulations and laws is the key to the intended market approval. SCC provides a broad spectrum of services, tailored to the specific needs of your products. We are your best choice if you plan and prepare your product for market approval: 

  • We offer trainings and provide templates to assist you file your technical documentation.
  • We provide comprehensive document creation services including evaluation plans, organisation of required tests and preparation of expert reports.
  • We help you deal with nonconformities identified during an audit or documentation review.

MDR (EU) 2017/745

For the EU member states, the transition period for the implementation of the new medical device regulation MDR (EU) 2017/745 has expired in May 2021. Compliance with the new European regulation is a requirement for the CE marking and approval of your medical devices.

As service provider, SCC pilots you through the new regulation, ensuring smooth implementation:

  • We offer training in which you learn how to implement the MDR in your company, helping you adopt the required procedures in line with ISO 13485.
  • In close collaboration with you, we perform a gap analysis and develop individual concepts aimed at re-establishing conformity.

Specific Requirements for Medical Device Approval

The detailed requirements for medical device approval are defined in numerous standards and guidelines:

Quality management systems in line with ISO 13485 and other standards

Quality management systems play an important role for manufacturers of medical devices. Our experts advise you on how to implement and optimise quality management systems and offer strategic, scientific and regulatory guidance on the implementation of quality-related processes, e.g. in R&D, production, and quality control.

Risk assessment of medical devices according to ISO 14971

One of the most important requirement with respect to safety and performance is the assessment of potential risks. Get informed how you can manage an internationally recognized risk management file with our help.

Biocompatibility of medical devices according to ISO 10993

All medical devices, which are intended to be in contact with the human body, need to be evaluated and tested within a risk management process according to ISO 10993-1. Find out how we can support you in the biological evaluation of your medical devices.

Substances of Concerns and Nanoparticles

Materials containing substances with carcinogenic, mutagenic and reprotoxic (CMR) properties and nanomaterials are increasingly coming into focus. Learn how SCC can help you keep up with the latest developments in REACH, RoHS or other requirements.

Clinical evaluation of medical devices

For CE compliance in the European Union, you need to set forth clinical evidences for medical devices of all risk classes. Take advantage of our experience in literature research and the preparation of a clinical evaluation.

Qualification and validation

Verification, qualification and validation play an important role in development, manufacture and quality control. Find out what you need to consider.

International approval

Take advantage of the marketing opportunities in other regions and countries and, with our help, obtain international approval for your products.

Contact Our Experts

Together with you, we develop an implementation strategy best fitted to your needs. Learn how our experts can help you to adopt the MDR requirements to your company with a minimum of effort.