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MDR · IVDR · ISO 13485
MedENvolve supports medical device and in vitro diagnostic manufacturers with regulatory strategy, technical documentation, clinical and performance evaluation, ISO 13485 quality management systems and audit preparation. We assess your intended purpose, available evidence and manufacturing processes together to develop a practical project plan.
Over 20 years of experience in quality, manufacturing, process development and regulatory affairs.
Medical device auditing roles since 2010.
Support spanning MDR and IVDR technical documentation, manufacturing controls and post-market activities.
OUR REFERENCES
WHO WE WORK WITH
Priorities change according to your product type and role in the supply chain. Choose the path closest to your organisation to review the relevant scope of work.
Integrated support for MDR strategy, classification, technical documentation, clinical evaluation and quality management systems.
VIEW DETAILSSupport for IVDR classification, performance evaluation, evidence planning and product-specific technical documentation.
VIEW DETAILSA practical roadmap for economic operator obligations, verifications, registrations and post-market processes.
VIEW DETAILSMEDENVOLVE CONSULTANCY
An IVDR project begins with classification and continues through scientific validity, analytical performance and clinical performance evidence. We support alignment between the performance evaluation plan and report, technical documentation, risk management, PMS and PMPF. Evidence gaps, required studies and submission priorities are assessed for each product.
We combine project experience with NGS-based IVD kits and IVF-related products with IVDR performance evaluation and quality management. We address consistency between scientific validity, analytical and clinical performance evidence, risk documentation and technical documentation on a product-specific basis.
EXPLORE IVDR SERVICES
We define the product and project scope.
We review existing documentation and evidence.
We identify gaps and responsibilities.
We plan documentation and verification activities.
We support submission preparation and responses to assessment questions.
TESTIMONIALS
“ As Growthimports, we are excited to announce that we have signed a partnership agreement with MedENvolve Consultancy. With over 15 years experience as a lead auditor for notified bodies in the medical device industry as well as being in charge of quality assurance for various medical device manufacturers, implementation of CE marking and ISO quality systems, MedENvolve auditors bring strong experience and regulatory expertise. ”
“ I would like to thank MedENvolve consulting company for guiding us and helping my team through the CE certification process. I hope we can continue this cooperation for many years. ”
USEFUL INFORMATION
0 CommentsMedENVolve Consultancy
Consulting on risk classification, technical documentation, performance evaluation and post-market surveillance for IVDR (2017/746) compliance.
READ MORE: What Is IVDR (2017/746) Consulting?0 CommentsMedENVolve Consultancy
We successfully completed the audit process conducted by HTCERT at Disposed Healthcare Products.
READ MORE: We Successfully Completed the Audit at Disposed Healthcare ProductsDO YOU HAVE A QUESTION?
Now. The MDR has applied since 26 May 2021; the transition periods have been extended, but the extensions depend on conditions and application deadlines. Call us today at (+90) 540 008 47 77 and we will assess the timeline that applies to your product.
If you market your device in the European Union (EU) under the MDD, note that there is no historical allocation of devices under the MDR. In addition, your device classification may have changed and may now require clinical assessment and renewal of the technical dossier.
The new EU Medical Device Regulation has broadened the scope of EU MDR applicability. Some products that were not previously recognized as medical devices are now covered by the medical device regulation. The newly added products include:
We know that the EU is a huge market for any medical device manufacturer and losing this revenue will have a negative impact on your business. We recommend you start by conducting a gap analysis of your current quality system and documentation. Contact us now using the consultancy request form. Our team of EU MDR experts will help you plan your next steps.
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