Medical Device
Solutions

Keep your medical devices compliant with changing technologies

Keep your devices compliant with rapidly changing regulations.

We help medical device companies access and stay compliant in the European and Chinese markets. To commercialize devices in the European Union, a CE Mark is required. For medical devices and in vitro diagnostic (IVD) devices, this means complying with the latest regulatory requirements.

Clinical Evaluation Reports (CERs) are a crucial, ever-evolving requirement for medical device manufacturers, and creating and updating them can be an intensive and complex undertaking. We support every aspect of the CER process—writing, reviewing, or consulting with you—to help you ensure the success of your regulatory strategy.

Under the new In Vitro Diagnostic Regulation (IVDR 2017/746), it is estimated that 80% of the current self-certified IVDs will be up-classified. This will mean involvement with a Notified Body and compliance with the latest regulations. If you are currently selling or plan on commercializing your IVD in the EU, we can help.

What We Offer

Post Market Surveillance (PMS) + Report, Periodic Safety Update Report (PSUR), and MDR Requirements

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)

Summary of safety and clinical performance (SSCP)

Clinical Evaluation Plan (CEP) development

Post Market Clinical Follow-up (PMCF) Plan

CER Remediation Support/Notified Body Response

Gap analysis of existing documents for EU MDR compliance

Gap analysis to IVDR

Regulatory pathway

Performance Evaluation Reports (PERs)

Benefit Risk Analysis (BRA)

Technical file review

CER format/QC support

Notified Body or FDA consulting support

Our Capabilities

Expertise

Our writing and reviewing pool has extensive experience in multiple areas of clinical evaluation across a vast array of therapeutic areas. Contact us if 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 questions.

Scientific approach

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 you are developing 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

Finalizing your documentation is not the end of the process, but just the beginning. We are available to consult with you at every step. We can partner with your regulatory team and help you keep your regulatory compliance current with periodic updates and yearly support.