Clinical and Post-Market
Demonstrate complete regulatory compliance by ensuring your in vitro diagnostic (IVD) device conforms to all applicable global requirements.
Delivering compliant IVD products to global markets
Choose Apotech for clinical compliance you can trust
Before placing an IVD device on the market, manufacturers must demonstrate compliance with all applicable global regulatory requirements including In Vitro Diagnostic Regulation (IVDR), 21 CFR and the UK MDR 2002.
At Apotech, our experienced team can make sure that you are conforming with the appropriate conformity assessment procedures. Working on your behalf, we can help you demonstrate that your IVD device achieves its intended purpose and corresponds to its claimed performance throughout its lifetime.
Trusted by top-tier teams worldwide
Why choose Apotech for IVD clinical and post-market services?
Article 56 (1) of the IVDR states that IVD manufacturers must specify and justify the level of clinical evidence given a device’s characteristics and its intended purpose. Therefore, defining this intended purpose must be considered a key driver behind its overall assessment.
Manufacturers must also ensure that they meet the essential requirements of the Medical Devices Regulations 2002 using data gathered through a performance evaluation.
At Apotech, we can support you during the clinical stages of your IVD development in the following areas:
FAQs on IVD clinical and post-market services
At Apotech, we provide a tailored approach to our IVD clinical and post-market services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Featured case studies
Regulatory Strategy IVDR / FDA
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Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking. Apotech Team Worked full time on the project: balanced…