With MDR in effect, either developing or maintaining (annual updates) Clinical Evaluation Reports (CER) becomes an important activity for device manufacturers.

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.

Critical Challenges

Small Manufacturers

  • Some companies don’t have in-house clinical teams
  • Tough to engage consultants for short periods (managing them, oversight of hours, quality checks)
  • Lack of literature search tools like Embase
  • Lack of strong Medical expertise

Large Enterprises

  • High risk devices need updates every year. Dedicating resources for the varying work loads is a challenge
  • In-house resources largely focuses on R&D projects and deviating them to life cycle activities is not easy always
  • Cross-functional collaboration extends the turn-around times and leads to “too many” emails/meetings loosing productivity

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 will assist you in completion of your PER projects in an efficient & compliant manner following Regulatory guidelines and Notified Bodies inputs.

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