Our Services at a Glance
Regulatory
We are familiar with international requirements coming from Authorities, Notified Bodies and Competent Bodies and will accompany your journey in the EU, US and markets in the rest of the world. It is essential, to determine the Regulatory Strategy as early as possible so you are able to follow the straightest route from development to product registration and marketing. This starts with correct product classification, followed by identifiying region/country specific regulatory requirements and product specific standards.
General Safety and Performance Requirements
GSPRs are the road map for writing your technical documentation and ensuring compliance with MDR 2017/745 respectively 2017/746 (IVDR) Details of GSPR requirements are defined in harmonized standards and depend on the kind of medical device. You can rely on our support to select and fulfill the appropriate requirements and find adequate justifications.
Technical File
The technical file gives insight to your device development process and shows that your product is acurately developed. The technical file is one main part of your submission dossier and must be handed over to authorities in specific STED format. Do not hesitate to contact us for help to prepare the STED file.
Risk Management
Risk Management according to ISO 14971 is a key element during life cycle of medical devices. A full risk assessment starts with risk identification, risk analysis and risk evaluation, followed by determination of risk-minimizing measures and evaluation of the acceptance of residual risks . This Risk Management process applies to all phases of the device lifecycle, including planning and product realization, design and development, purchasing, service, and change control. It should be noted, that several types of hazards that need to be evaluated, including energy, biological, environmental, software, user error, labeling, complexity of use, and functional failure hazards.
Usability
Based on the requirements of ISO 62366 and/or HE 75 we help to improve the design and user-friendliness of your medical devices. We ensure that your products comply with regulatory requirements and can be operated intuitively and error-free.
We support your test planning and execution of tests to analyse the user-friendliness of your products, human factors engineering and evaluation of usability tests in order to continuously optimise your products.
Biocompatibility
We will help to fulfil ISO 10993 requirements for your devices from planning to interpretation of test result and final biocompatibility report. We support both, early-stage evaluations and remediation activity for your existing product portfolio. We also assess the biological hazards of proposed materials to ensure patient safety.
Clinical
We will advise on and prepare your Clinical Evaluation Plan (CEP) and Report (CER) and support you with the preparation of your Post Market Clinical Follow-Up (PMCF) plan and PMCF reports. For high-risk devices, we will help in creation of your Summary of Safety and Clinical Performance (SSCP)
Quality
An ISO 13485 certified (CE) and MDR IVDR compliant QMS, resp. QSR/QMSR/MDSAP compliant QMS is fundamental for compliant product development and marketing. We help to define the processes necessary for your company and help to improve existing processes. We can also support you in the execution of these processes. This QMS forms the basis for successful product certification and also creates transparency and acceptance of your various corporate processes.
Product Registration
We can manage, implement, or collaborate on the registration procedure of your medical device in Europe (CE marking), the US (510(k), PMA) or the rest of the world. We support the registration work on your behalf from preparation of technical documentation, to making the submission to and co-operation with notified bodies or authorities. Together, we navigate on a straight-forward path to product certification.
Person Responsible for Regulatory Compliance - PRRC
According to MDR Article 15, small enterprises shall have a PRRC permanently and continuously at their disposal.
We can act as your PRRC and be responsible for
- Product conformity and product release
- Preparation and updating of technical documentation and EU declaration of conformity
- Post-market surveillance
- Reporting of serious incidents to authorities and field safety corrective actions
- Verification of the submission of a statement in the case of investigational devices.
Authorised Representative – EU Rep
MDR Article 11 requires, that non-EU manufacturers must designate a sole authorised representative (EU Rep). Upon request the EU Rep shall provide a copy of the mandate to the competent authority.
EU Rep responsibilitiy includes, but is not limited to:
- Registration your devices in EUDAMED
- Representation on your device labelling
- Regulatory review of your technical documentation
- Contact for Post-Market activities
Post Market Activities
MDR and IVDR Annex III require either a “Post-Market Surveillance Report” (class I /A medical devices) or a “Periodic Safety Update Report” (class IIa /B and higher) from medical device manufacturers. We help manufacturers to create and present the PMS or safety report (PSUR) as part of the technical documentation in clear, organized, easily searchable and unmistakable form.
