Leading the way through laws and standards
In Europe, medical devices are subject to clear legal requirements: Products can only be placed on the market if the manufacturer has proven that they are safe and perform their function. We help you to interpret the requirements set out in laws and standards and to implement these in practice. To do so, we can provide targeted support on individual topics according to your needs, or we can accompany you through the entire development process.
Conformity assessment and technical documentation
You and your experts know your products and technology inside out. At Schrack & Partner, we simply add to your own development team, making sure that you clear every hurdle on your path to authorisation. To obtain a CE marking in the EU and to pass authorisation and registration processes around the world, you need viable device verification and validation strategies, as well as professional documentation processes. With our help during your development process, you can rest assured that your development outcomes and the corresponding documentation will comply with the applicable laws and standards at every stage.
From the device requirements profile to pre-clinical and clinical evaluation, all the way to the creation of a viable concept for post-market surveillance – we help you to implement the following European directives and regulations. When doing so, of course, we take into account all equally applicable legal policies, guidelines and standards. During the transition period we help businesses to convert to the new rules:
- From Directive 93/42/EEC on medical devices to Regulation (EU) 2017/745 on medical devices
- From Directive 98/79/EC on in-vitro diagnostics to Regulation (EU) 2017/746 on in-vitro diagnostics
- From Directive 90/385/EEC on active implantable devices during the transition period to Regulation (EU) 2017/745 on medical devices
Give us a call. We have the perfect service package to answer your questions!
Innovative medical devices and new technology: How are device certification and authorisation processes performed internationally?
We work closely with your experts to analyse the applicable legal guidelines, support you during the classification process, and help you to develop authorisation strategies. If required, we can organise consultations with notified bodies and authorities on your behalf, enabling you to clarify any borderline cases relating to classification and conformity assessment procedures. Our services help you to analyse your potential courses for action and to establish a basis for successful device certification and authorisation using a viable strategy.
A challenge set to last a while: Converting to the new EU regulations
We help businesses to plan and implement the reassessment of their products. To do so, we work with you to create concepts for both reassessing existing products, and redesigning and converting development processes. Our project and work packages can deal with the following issues, as well as many more:
- Review and delta analysis of technical documentation and design dossiers with respect to conformity with applicable and upcoming EU regulations
- Developing requirements profiles for the reassessment of products and product groups, including subsequent support during verification and validation planning
- Creating concepts for the reassessment of technical documentation
Our service packages for your development projects
We accompany your development projects in a specialised, needs-based manner, ensuring that you comply with the applicable requirements set out in laws and standards throughout every stage of the development process.
You decide whether we provide continuous support, from the specifications stage to market launch, or targeted assistance regarding individual questions. Our service packages can deal with the following issues, as well as many more:
- Support during the creation of user and product requirements specifications
- Support during the creation of risk management plans, moderation and documentation of risk analyses, and derivation of action plans
- Support during the development of the verification and validation plan. Based on the applicable standards and the results of the risk analysis, we collaborate with your experts to create viable verification and validation plans for pre-clinical evaluation. We can help you to select testing methods and expert testing laboratories in order to push forward with implementation. Additionally, we are happy to help you to present, summarise and evaluate your results.
- Support during the clinical evaluation process: Alongside our partner, novineon CRO GmbH, we can offer to create a clinical evaluation strategy for you, including a scientific appraisal of the available literature. If required, at the end of the project our partners can create a clinical evaluation report and help you to develop a sturdy, feasible concept for post-market clinical follow-up.
- Support during the design transfer and industrialisation processes: Using risk management tools, we help to identify critical control points and processes requiring validation. During implementation, we can help your teams to plan validation, evaluate the results and create reports.
Do your development teams need support when it comes to documentation?
We can take over parts of the development-related documentation process. Our employees work on these projects using the processes set out in your QM system. Potential service packages in this field include:
- Creation of technical documentation and/or the design dossier during development
- Support during the creation of documents relating to the development process, e.g. user and product requirements specifications, design review documentation, traceability matrix, verification and validation plans and reports
- Support during risk analyses and documentation of the analyses, as well as derivation of action plans
A long-standing requirement in directives and a key focus of EU regulations: Post-market surveillance by the manufacturer
We will review your existing post-market surveillance procedures. Together, we will ensure that your procedures comply with the applicable regulations and develop concepts for your product range. We also offer support during the creation of product-related plans for post-market surveillance and subsequent evaluations and report creation.