Regulatory and Strategic Support for Successful Market Compliance
Our Services for Newcomers and Established Companies
Medical devices are highly regulated and subject to strict performance and safety requirements. An effective route to a broad market presence can help quickly recoup your development investments.
With more than 20 years experience in the medical device industry, we have a perfect understanding of the needs and challenges of your business. We support you with all services you need for your medical device approval and pave the way to your success.
Our services include:
- International market access strategies
- Globally compliant quality management systems
- MDR (EU) 2017/745 compliance services
- Risk management according to ISO 14971
- Biocompatibility in line with ISO 10993
- Expert advice on dealing with critical substances
- Clinical evaluation and literature research
- Qualification and validation
Together with you, we develop an implementation strategy best fitted to your needs
Learn how our experts can help you to adopt the regulatory requirements to your company with a minimum of effort.
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.
International Market Strategies for Medical Devices
One of the greatest challenges for the industry is the diversity and complexity of regulatory systems in different countries.
We advise on how you can develop the best market entry strategy for your medical devices in the target markets:
- For conformity assessments, we help you design your tests and studies to ensure broad international acceptance.
- We maintain an overview of developments in potential markets for your medical devices to help you recognise potential regulatory hurdles in advance and get your products and documents fit for future challenges.
- We develop strategies for cost-efficient market access for your medical devices.
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 Concern 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.