Clinical Evaluation Report (CER)
Over the years, we have perfected the clinical evaluation process.
European Union (EU) Medical Device Directive (MDD) and Medical Device Regulation (MDR) Clinical Evaluation Report (CER) writing is one of Global’s core strengths. We have worked tremendously hard to become a leader in the medical device industry in this space. We are the go-to resource for 4 of the Top 10 large-cap medical device companies and we handle entire portfolios for numerous mid-cap companies. We’ve developed a hard-earned reputation of tackling the toughest projects on-budget and in record time.
We come to the Kick-Off Meeting with a targeted strategy and lead the collaboration with your key stakeholders through the entire process:
Author CEP, CER, PMS Plan and PMCF Plan
Collect, assess, and analyze all available data
Identify your clinical gaps and any weaknesses in marketing claims
Develop cost-effective PMCF activity solutions for your gaps that will be acceptable to your Notified Body
Our exposure to a wide variety of products and Notified Bodies gives us unique insight into:
Industry-wide best practices
Patterns of Notified Body expectations
Proven strategies that will save you money and time
We get it right the first time.
Device manufacturers rarely have enough dedicated, trained CER writers on staff to address the full scope of their portfolios. We estimate there are at most 150 capable CER writers in the United States. Those who know what they are doing are expensive. Those who are cheap do not know what they are doing.
It is integral to your success that you have writers with a robust understanding of the ever-changing and increasingly intricate MDR requirements.
With more importance than ever placed on the clinical evaluation, each CER Project requires undivided attention and expertise. The CER is a foundational document that will support your device for decades to come. Invest in getting it right the first time. The MDR deadline is rapidly approaching. Your market share is on the line.
Our CER Specialists excel at translating complicated regulations into clear, actionable plans and effective deliverables. We tailor individualized strategies for each CER, prioritizing our clients’ goals and familiarity with their products at every step. We communicate closely with your expert stakeholders so there are no surprises.
What Makes Us Special
Every CER is assigned a team of professional CER Specialists. Every specialist is a writer-project manager-MDR expert trained in recognizing gaps to minimize non-conformities and Notified Body findings.
Our CER experience includes all device classes, from legacy to first-in-kind devices, and encompasses an extensive range of therapeutic specialties. However, we specialize in CER submissions for high-risk devices: Class IIb, Class III, implantables and active implantables.
We Can Prove It
Our track record speaks for itself.
The Global CER Team has authored hundreds of MDD Rev 4 and MDR CERs for dozens of manufacturers and all the most important Notified Bodies. Over 40 CER Specialists are at the ready, most of whom hold advanced degrees (MD, PhD, PharmD, etc.). Our time-tested team structure and writer partnerships allow for parallel efficiency, cost savings, and submission success.