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
- Were clinical performance studies and tests performed to prove a device is effective and safe?
- What analytical tests were performed and what standards are used?
- What recorded evidence exists for the device?
- What research has been conducted on the device and it’s intended purpose?
- What state-of-art the device corresponds to?
- Was Scientific Validity as per guideline (like IMDRF suggestive inputs)
Our Services & Benefits
- Customized support for all – large, medium and small manufacturers
- Dedicated team of 90+ experienced scientific specialists, medical/technical writers and bio-medical experts
- Experienced in collating important information from various publications as well as multiple source reports like safety, complaints, marketing, change management and clinical reports
- Experienced in all major literature search referring protocols, reports, equivalent devices and others
- Strong experience in all relevant sections of the relevant guidelines including IVDR, IMDRF guidelines and others
- Help manufacturers summarize Safety/Vigilance and product complaint data
- Medical and Regulatory specialists to oversee & guide on critical requirements on end to end deliverables
- Direct time and cost efficiencies
- FSP, 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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