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IVD Clinical Evidence

IVDR compliance is not far. Some companies updated their clinical reports while vast majority of them have not Based on the risk class,
requirements for clinical evidence increase to support the safety and performance of your products.

Performance Evaluation

From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP), as well as a file of clinical evidence should be combined as a performance evaluation report (PER).


Some of the questions that these reports need to address:


  • BulletWere clinical performance studies and tests performed to prove a device is effective and safe?
  • BulletWhat analytical tests were performed and what standards are used?
  • BulletWhat recorded evidence exists for the device?
  • BulletWhat research has been conducted on the device and it’s intended purpose?
  • BulletWhat state-of-art the device corresponds to?
  • Bullet Was Scientific Validity as per guideline (like IMDRF suggestive inputs)

Our Services & Benefits:

  • BulletCustomized support for all - large, medium and small manufacturers
  • BulletDedicated team of 90+ experienced scientific specialists, medical/technical writers and bio-medical experts
  • BulletExperienced in collating important information from various publications as well as multiple source reports like safety, complaints, marketing, change management and clinical reports
  • BulletExperienced in all major literature search referring protocols, reports, equivalent devices and others
  • BulletStrong experience in all relevant sections of the relevant guidelines including IVDR, IMDRF guidelines and others
  • BulletHelp manufacturers summarize Safety/Vigilance and product complaint data
  • BulletMedical and Regulatory specialists to oversee & guide on critical requirements on end to end deliverables
  • BulletDirect time and cost efficiencies
  • BulletFSP, FTE & full service project models


MakroCare with a global team of 90+ Clinicians, Diagnostic technologists, Micro Biology associates, Writers, and Scientific experts can help you achieve your Performance Evaluation goals, on time with scalable competitive cost models (unit, hourly, fte).


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The First Step

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