Medical devices expertise
Technical expertise and direct access to recognized experts are worth their weight in gold – put it to the test with our Regulatory Kick-Start!
Expertise in all aspects of the regulatory requirements for your medical devices in accordance with the EU MDR / IVDR regulations
The EU declaration of conformity – a prerequisite for placing medical devices or in-vitro diagnostics on the market in accordance with the EU MDR / IVDR regulations – is essentially based on proof of compliance with “essential safety and performance requirements” through “harmonized standards” and “common specifications”.
Do you need active support with the general requirements, risk management in accordance with ISO 14971:2019+A11:2021 or usability in accordance with EN 62366-1:2015+A1:2020?
We help you to implement the “Essential Requirements” and other key standards for the most important product categories.
When it comes to testing activities, it is our “Trusted Partners” who provide you with seamless “hands on” support.
- EN 62304, EN 82304 resp. AMII TIR45
- ISO 10993-1:2018
- EN 60601-1-x, EN 60601-2-x
Risk management for medical devices and IVDs
With the “Risk Management Toolbox”, we offer you a risk management process in accordance with ISO 14971:2019+A11:2021, which has been “approved” many times in audits. We also provide all the tools and templates for creating the risk management plan and risk analysis. We train you and your employees in the implementation of risk management and, if required, we organize, moderate and document your risk management meetings or support you as an independent expert in the mandatory risk management review.
With the help of our tools and decades of experience (e.g. as a member of the ISO 14971 standards committee, 10 years as a lecturer at universities of applied sciences), your risk management becomes a tool for an excellent risk/benefit ratio.
Are you unsure what the MDR requires in terms of risk management or which basic safety and performance requirements must be met by risk management? Would you like clarity as to whether your risk analysis complies with the standard?
Our “Risk Management Check Standard” checks your approved and final “risk management file” to ensure that it is in the correct formal form and is complete and plausible. We randomly check the “risk management file” for consistency of content and typical deficiencies based on our experience.
In this way, you avoid the typical pitfalls, such as incomplete risk management plans, insufficient implementation and traceability of the “as-far-as-possible” principle in the risk policy and in the individual risk-reducing measures.
Medical device software MD and IVD
Software now plays a central role in the world of medical devices. What do you need to bear in mind here?
Whether embedded software, medical apps or artificial intelligence (AI), questions about EN 62304, EN 82304 or AMII TIR45 arise immediately.
With more than ten years of experience in implementation with leading European manufacturers, we support you with tried-and-tested solutions.
With the help of en.co.tec, mySugr succeeded in launching one of the first medical apps, the “mySugr Logbook”, as a medical product in cooperation with the notified body TÜV SÜD Product Service GmbH. We succeeded in doing real pioneering work in this domain, from which you can benefit today. Since then, we have been able to provide the company – now a medium-sized enterprise – with comprehensive support for all new medical apps and the quality management system. This also applies to the MDR changeover, MDSAP certification or when tricky technical/regulatory issues arise.
We will be happy to accompany you on your journey from development to market readiness for your embedded software, medical apps and artificial intelligence (AI) and work with you to ensure that you comply with all relevant standards, guidelines and regulatory requirements.
Fitness for use for medical devices and IVDs
Recognizing that around 1/3 of all “incident reports” are caused by deficiencies in the usability of medical devices, the FDA published the guideline Applying Human Factors and Usability Engineering to Medical Devices*. Manufacturers use these guidelines just as we do when implementing suitable human factors and usability engineering processes.
We support you in the implementation of usability-oriented development processes in accordance with EN 62366-1:2015+A1:2020 and AAMI HE 75 in the quality management system, the planning of usability validation and, together with usability test labs, in their implementation.
Biological assessment for medical devices
The use of biocompatible materials in medical devices guarantees a high level of patient safety. The agony of choice begins with product development. Mistakes made here, e.g. when selecting materials or deciding on a suitable supplier (keyword – quality assurance agreement “QAA”), can only be rectified later at considerable expense in terms of time and money. The decision for a contract manufacturer is particularly tricky when it comes to medical devices containing substances (MDR Annex VIII/Regulation21).
We are here to support you:
- in product development for the risk management required by ISO 10993-1:2018,
- in supplier qualification (e.g. supplier audits),
- when planning the validation of medical devices in accordance with ISO 10993-1:2018 and
- when checking whether your medical devices also fulfill all other product-specific biochemical “Essential Requirements” according to Annex I of the EU Medical Device Regulation.
Together with biocompatibility test laboratories, we help to carry out biocompatibility tests for suitability for use.
Medical electrical equipment – General requirements for the safety and essential performance of medical devices
IEC 60601-1 deals with the basic safety and performance requirements for medical electrical equipment and systems. It ensures that no unacceptable risks arise for patients and/or operators under normal and faulty conditions.
IEC 60601-1 defines a wide range of requirements for active medical devices, e.g. with regard to electrical, mechanical, thermal and functional hazards, and with its collateral IEC 60601-2-x standards for over 50 product categories (e.g. ventilators, infusion pumps, dialysis machines, etc.) represents the state of the art.
It is essential to know and consider the standards during product development! Mistakes made here can usually only be rectified later with additional iteration loops and almost always mean a longer time-to-market.
We are here to support you:
- during product development for the risk management required by EN 60601-1:2013,
- in supplier qualification (e.g. supplier audits),
- in the planning and implementation of cost-effective pre-tests.
Together with ISO 17025 accredited test laboratories, we support you in product testing in order to test the products according to various standards for electromagnetic compatibility, environmental and electrical safety and performance.
A consultation for your medical devices at en.co.tec
From our many years of experience in a wide range of medical devices and in-vitro diagnostics of all categories and risk classes in many areas of the industry, we can offer you comprehensive specialist know-how and an excellent network from which you can benefit.
Our broad network for manufacturers of medical devices and in-vitro diagnostics ranges from notified bodies to accredited test labs for electrical safety testing, biocompatibility and usability testing. Service providers such as Contract Research Organizations (CRO’s), clinical trial sites, certified medical device hardware and software development service providers, UDI issuing bodies etc. support you in all aspects of medical device development.
Our consultants will be happy to bundle this entire process for you.
You are at the center of everything we do – your needs and requirements for advice on your medical devices are comprehensively covered by our experts together with the tried-and-tested network that has developed from practical experience. Bring this medical device expertise to your company!
Our training courses & events
Are you interested in the approval of medical devices in general and want to acquire knowledge about it yourself? Our training courses and events will provide you with information and teach you more about the requirements and how you can implement them effectively.
Benefit from the practical knowledge and information provided by our professionals – training courses are also available on site at your company or online. We look forward to hearing from you!
We have already worked with many companies and experts – here you will find an overview of our references:
We are happy to support you in all areas relating to regulatory affairs and quality management for your medical devices! Benefit from the knowledge of our consultants and get in touch with us.
Do you want to expand your knowledge and successfully implement requirements relating to medical devices? Take a look at our calendar of events and book your place on one of our training courses today – we look forward to seeing you!
