DSC_1321

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.

Smiling group of diverse businesspeople going over paperwork together and working on a laptop at a table in an office

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: 

  • Data establishment
  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • Post-Market Performance Follow-Up (PMPF)
  • Validity
  • Analytical performance
  • Clinical performance

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

Process and Test Method Validation Review and Improvement

Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…

Read More

Software as a medical device (SaMD)

Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regulatory affairs Responsible person FSP Scope of work Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK…

Read More

EU-IVDR Technical File Remediation

EU-IVDR Technical File Remediation Introduction In Vitro Diagnostic Manufacturer Our client is a leader in high-quality, innovative diagnostic products for the determination of blood groups (anti-Duffy and anti-Kidd). They are located in the US with operations globally. Standards & Tools EU-IVDR 2017-746 ISO 13485 ISO 14971 GDPR Word Excel Powerpoint Scope of work Key numbers…

Read More

Ready to get started?