These are the first 70 professionals to ever earn their RCC credentials

RAPS announced today the names of the 70 professionals who passed the first-ever Regulatory Compliance Certification (RCC) exams, which took place in autumn 2023.

Each professional listed below has earned their RCC-MDR or RCC-IVDR designation. To pass their RCC exam, individuals must demonstrate specific knowledge correlated to the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR), respectively.  Manufacturers around the world must comply with these regulations in relation to devices and IVDs placed on the market in the European Union.

These are the first professionals to earn the RCC credentials.

“On behalf of RAPS, I offer my congratulations to all of the professionals who passed the first-ever RCC exams,” said RAPS Executive Director Bill McMoil. “This group embraced a new credential and proved their commitment to the regulatory profession. RCC credential holders will help institutions bolster regulatory affairs compliance and risk mitigation at organizations around the world."

The deadline to sign up for a spring 2024 RCC exam is 22 February. Learn more here.

The RCC is the newest credential for regulatory professionals in the healthcare product sector. It is intended for Persons Responsible for Regulatory Compliance (PRRCs) and individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. It shows employers, clients, and colleagues that a regulatory professional has the essential knowledge required for regulatory compliance in the healthcare products sector. These voluntary designations do not qualify individuals to serve in the PRRC role, nor do they guarantee that an individual meets all the requirements necessary to practice as a qualified PRRC.

RAPS created the RCC credentials with input and contributions from regulatory professionals, including an expert task force of industry leaders who discussed early concepts and a group of subject-matter experts who helped RAPS build the exams.

“Congratulations to our first-ever RCC credential holders for earning these new certifications,” said RAPS Credentialing & Professional Development Director Jennifer Naughton. “RAPS would not have been able to create these credentials without the involvement and expertise of the many subject-matter experts, whose contributions we greatly appreciate.”

RAPS is now accepting applications for the 2024 RCC exams. Learn more about the RCC exam schedules, application instructions, and more.

Following is the complete list of those who earned their RCC credentials during the first-ever exam window:

RCC-IVDR passers

RCC-MDR passers