Keep your devices compliant in the rapidly changing regulatory landscape
CACTUS MDS is here to help medical device companies access and, critically, stay compliant in the European and Chinese markets. Clinical Evaluation Reports (CERs) are a crucial, ever-evolving requirement for manufacturers, and creating and updating them can be an intensive and complex undertaking. We support every aspect of the CER processu2014writing, reviewing, or consulting with youu2014to help you ensure the success of your regulatory strategy.
Our capabilities
Expertise
Our writing and reviewing pool has extensive experience in multiple areas of clinical evaluation across a vast array of therapeutic areas. Whether you have a group of regulatory writers who need help with the volume of work or your company has never written a CER before and have a long list of questions, our team is ready.
Philosophy
Regulatory strategy can be as much a business decision as it is a thoughtful scientific rationale. We approach every project with an understanding of the multitude of business implications for your company as well as a reasoned, critical scientific analysis based on your data and objectives.
Scalability
Whether this is your first device or you manage a therapeutic area for a multinational conglomerate with hundreds of devices, we have the team ready to help you succeed. We're happy to support your company on individual projects or to partner with you to support your regulatory compliance strategy in the long term.
End-to-end support
Once a CER is finalized, it is not the end of the process, but just the beginning. We are available to consult with you from ideation all the way through Notified Body responses and beyond. Cactus MDS can help you keep your CER current with periodic updates and yearly support as a partner to your regulatory team.
What we offer
- New Clinical Evaluation Report (MEDDEV 2.7.1 REV 4 and EU MDR)
- Update of an existing Clinical Evaluation Report (under new EU MDR guidelines)
- Clinical Evaluation Plan (CEP) development
- Post Market Surveillance (PMS) + Report, Periodic Safety Update Report (PSUR), and MDR Requirements
- Summary of safety and clinical performance (SSCP)
- Post Market Clinical Follow-up (PMCF) Plan
- Benefit Risk Analysis (BRA)
- CER Remediation Support/Notified Body Response
- Gap Analysis of existing documents for EU MDR compliance
- CER format/QC support
Connect with CACTUS
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