Clinical Evaluation Report (CER)
With Rev 4 in effect already and MDR in horizon in next couple of years, developing and maintaining Clinical Evaluation Reports (CER) became higher priority for device manufacturers.
Unlike previous versions, CER Rev 4 has some of the requirements that are very different and just updating based on literature strategy alone will increase your risk of rejection. As Rev 4 needs “Equivalence / Predicate” to be seen from a different perspective, right team of medical, regulatory, technical and scientific disciplines is key to ensure higher quality of CER that’s not only satisfies NBs but also conveys right information to healthcare community.
As a solution provider, MakroCare offers right strategy starting with Gap Analysis of your existing CER (if an Update is needed), all available data from clinical to safety to risk management to literature before arriving on right CEP. Based on the designed plan, next steps of execution are undertaken with right teams located globally to ensure scale, speed and quality.
Our Services & Benefits:
- Customized support for all - large, medium and small manufacturers
- Dedicated team of 60+ 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 to relevant sections of the relevant guidelines including MEDDEV 2.4
- 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 will assist you in completion of your CER projects in an efficient & compliant manner following Regulatory guidelines and Notified Bodies inputs.