Consulting & Support in Regulatory Affairs
Medical Device Regulatory Guidance bundles our consulting services from the product idea to placing the medical device on the market. With customized consulting products, our consultants and network partners use their experience to guide you safely through all the stages up to market launch. It doesn’t matter what risk class your medical device is, where you are at the moment, or where you want to place your product on the market for the first time.
Regulatory Affairs – Product Authorization according to MDR and IVDR
Are you a start-up at the beginning of development, or are you an SME looking to enter the medical device market and want competent and individual answers to the typical questions that arise?
With the “Regulatory Strategy Workshop”, we offer you a systematic analysis of the current maturity level of your product and your organization and jointly develop a roadmap up to the initial marketing of your product. With the help of our experience, you can avoid expensive and time-consuming mistakes.
Are you unsure whether your product is a medical device at all and, if so, which risk class it falls into? Are you unsure which components of your product should be declared as medical devices and which as accessories?
With our “Support with delimitation issues”, we help you to prepare a delimitation application for the authorities. With our experience and our contacts with the authorities, we support you in clearly formulating the intended purpose of your product and providing the corresponding justifications so that the decision on the delimitation procedure provides a legally sound basis for all further steps.
Are you facing the task of developing a medical product for the first time and are you a start-up, or are you an SME and repeatedly have deviations in your development processes during audits?With “Process Audits Design and Development” or “Supplier Audits”, we put existing development processes or development service providers through their paces and tell you exactly where they currently stand. With the help of our independent audits, you will receive clear findings on where and how you can reduce the risk of deviations in relation to regulatory requirements and, above all, many practical tips on how you can improve your own development processes.
With the “Technical Documentation Review Support”, our independent experts accompany your development assessments with a focus on traceability and technical documentation. With the help of this independent and expert view of your documents, you receive timely feedback and can identify and rectify any shortcomings in good time.
With the “Quality Management Process Support”, we jointly document your development processes in accordance with internationally recognized medical device standards (ISO 13485, EN 62304, EN 62366 AMII TIR 45). This ensures that your development projects comply with the EU regulations for medical devices (MDR/IVDR) and the “Design Controls” of the FDA (USA) and at the same time provide the essential content of the “Technical Documentation”.
Are you a StartUp and already have the first prototypes or are you an SME and already have a medical device [MD] or in-vitro diagnostic [IVD] on the European market – but do not yet have a notified body or want to change it?
Our “Notified Body Access Service” helps you to find a notified body and opens doors for you that would otherwise remain closed. We establish contacts, organize the appointments, accompany you to the initial meetings, fill out the various forms together and finally check the offers so that everything runs smoothly right from the start.
Our “Technical Documentation Check Standard” checks your approved and final “Technical Documentation” to ensure that it is in the correct form and is complete and plausible. We randomly check the technical documentation for consistency of content and typical shortcomings based on our experience. This allows you to avoid typical pitfalls, such as the fact that the intended purpose does not match exactly in different documents.
Our “Technical Documentation Check Detailed” requires the “TD Check Standard” and checks individual sections of the “Technical Documentation” in detail, for example the “Clinical Evaluation”, the “Risk Management”, the “GSPR’s”, the “UDI’s” and more.
Our “Technical Docu-FollowUp Support” requires the “TD-Check Detailed” and supports you in the event of queries from the Notified Body regarding the sections we have checked.
Our offers for Regulatory Affairs
We support you simply and quickly with our offers:
Consulting services:
- Regulatory Kick-Start: Clarify individual questions relating to the In Vitro Diagnostics Ordinance and the Medical Devices Ordinance.
- Regulatory Strategy Workshop: Systematic analysis of the current situation and development of a roadmap through to market launch.
- MDR-IVDR gap analysis: Internal company workshop to discuss and plan the specific effects and measures.
Regulatory News:
- Regulatory-Newsletter: Regular briefing on essential topics – only content that is really important to you.
- LinkedIn-Company page: Regulatory news for medical devices and IVDs in real time
Seminars:
- Current seminar dates: Quick overview of MDR, IVDR and all requirements for medical devices and IVDs
- MDR-IVDR seminar: in-house training on the new EU MDR and IVDR regulations
Regulatory affairs covered by en.co.tec
We support you in the approval process for medical devices – every collaboration begins with an initial audit. As a first step, we review your internal management systems and identify weaknesses and potential. Our professionals then support you with the following services:
- Cooperation with the authorities and notified bodies, Preliminary discussions on delimitation issues, determination of detailed verification requirements (e.g. clinical data, standards, etc…)
- Compilation of technical documentation: Preparation and implementation of documentation in accordance with the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostics Regulation (IVDR).
- Approval of your medical deviceor IVD in Europe, USA (FDA – 510k approval for your medical device)
- Seminars & Trainings: CE marking for medical devices and IVDs, FDA approval, international approval, FDA inspection training
Practical relevance plays a major role in all our services, as each of our consultants comes from a practical background and aims to optimize implementation, organization and execution.
Our training courses & events
If you want to take regulatory affairs in your company into your own hands, then attend one of our training courses. During the training course, you will benefit from the practical knowledge of our regulatory affairs professionals – We look forward to seeing you!
Our references
We have already worked with many companies and experts in the field of regulatory affairs – here you will find an overview of our references:
Do you also need help with the management of regulatory affairs?
Do you need support with MDR or IVDR in relation to your medical devices? Then get in touch with us – you can register online for an initial consultation or take part in our training course! We look forward to seeing you!
