The new Medical Device Regulation (MDR) introduces many new requirements on the medical device market. It represents a major challenge for medtech companies.
PlantVision has an experienced multidisciplinary team, covering a broad range of resources, expertise, and services, who can provide you with continuous support over the implementation and transition period to MDR.
Customized MDR services to meet your specific needs
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MDR seminars & workshops
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Gap analysis
– Gap analysis workshop
– Transition plan MDD to MDR
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RA support during transition and/or market access process
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PlantVision Academy courses and customized training
An important area where PlantVision can provide support is in helping your organization gain a good understanding of the new regulation and its requirements. This can be achieved through tailormade courses or workshops, where we help you to identify your company’s specific needs.
We can help you to efficiently define your transition plan by carrying out a thorough MDR gap analysis in order to identify where your company currently fails to comply with MDR. This includes a detailed follow-up report with recommendations for what actions should be taken.
You can also ensure continuous support during your transition process through our Compliance Partner service, which provides fast and efficient access to experienced consultants. Our consultants are equally capable working in English or Swedish.
How can we support your organization?
Ewa Kloskowska
Head of Unit,
Medtech and IVD
ewa.kloskowska@plantvision.se
Tel: +46 (0)73 092 01 34
PlantVisions professionella bemötande och entusiasm fick oss att välja dom som leverantör för att hjälpa oss på vår väg mot MDR certifiering. Vi är mycket nöjda med samarbetet då vi har fått snabba återkopplingar, ser resultat och att vi tillsammans har skapat en stimulerande arbetsgrupp.
PlantVisions professionella bemötande och entusiasm fick oss att välja dom som leverantör för att hjälpa oss på vår väg mot MDR certifiering. Vi är mycket nöjda med samarbetet då vi har fått snabba återkopplingar, ser resultat och att vi tillsammans har skapat en stimulerande arbetsgrupp.
Find out more about MDR
PlantVision Academy is partners with Swedish Medtech, Swedish Labtech and Läkemedelsakademien. We offer a wide range of courses together with our partners, as well as providing tailored training that can be adapted to your organization’s specific needs.
Are you aware of all changes from MDD to MDR and how they will affect your organization?
With the introduction of MDR, all economic actors need to update their quality systems with respect to certain key areas. We have a deep understanding of the gap between ISO 13485 and the additional requirements placed on quality systems relating to MDR. We can support you with everything from overall strategy, to the development of individual SOPs. We can also help with the set-up and certification of complete quality systems, regardless of whether you are a manufacturer, distributor or importer.
Timeline for updating quality systems regarding MDR.
For high-classed products, manufacturers estimate that around half of their MDR transition costs relate to clinical data requirements – whether these result in new clinical evaluations (CER) or clinical studies. In either case, we have teams that are highly efficient in producing documentation according to the latest requirements and also have experience from preclinical and clinical studies for medical devices.
Validation of computerized systems is always in focus. Even computerized support systems must have a validated status – which is something that often ends up towards the bottom of a company’s list of urgent measures. We have a large number of validation managers and validation engineers who can safely and efficiently help you with both validation strategy and execution.
Whether it relates to electrical safety or other standards, we have solid experience in managing and carrying out third-party testing. From planning product development and setting up a test strategy, to resolving tricky deviations. Our approach to coordinating testing activities can also be very useful for the development of your operations and product design function.
Read more in our article on electrical safety for medical technology »
