PRRC Services, for organisations requiring accountable regulatory oversight
External PRRC support under EU MDR and IVDR, to ensure your devices remain compliant throughout their lifecycle.
PRRC is a legal requirement.
Regulatory accountability is personal.
Under EU MDR and IVDR, manufacturers must appoint a Person Responsible for Regulatory Compliance with the expertise and authority to oversee regulatory obligations.
For many organisations, particularly growing manufacturers, maintaining that level of regulatory oversight internally can be difficult.
The role carries responsibility across product conformity, technical documentation, vigilance and regulatory reporting.
External PRRC support ensures that accountability is properly maintained.
How we support organisations
PRRC support designed to maintain regulatory accountability across the product lifecycle.
PRRC Appointment and Ongoing Support
We act as your external Person Responsible for Regulatory Compliance under MDR or IVDR, ensuring regulatory responsibilities are continuously fulfilled.
Post-Market Surveillance & Vigilance
We assess PMS systems and vigilance reporting processes to ensure device performance is monitored and regulatory reporting obligations are fulfilled.
Product Conformity Oversight
We oversee product conformity assessments to ensure devices meet regulatory and quality system requirements before being placed on the market.
Technical Documentation Management
We review technical documentation and declarations of conformity to ensure regulatory expectations are properly met.
Regulatory Compliance Training
We support internal teams with targeted training and guidance on regulatory and quality system responsibilities.
Why choose The Other Consultants?
Independent auditing shaped by real certification experience.
UKAS-witnessed Lead Auditor
Independent and objective
Certification body and notified body perspective
Over 50 ISO 13485 and MDR audits conducted
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"Just to let you know that today’s audit on design didn’t raise any CARs...
they accepted that we had a strong internal audit conducted and that our QMS was working and flagging issues”
PRRC of a IIa medical device manufacturer.
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“Adam is a breath of fresh air when it comes to QARA...
…he takes the time to understand the needs of a client and communicate effectively. He is not afraid of a challenge and always goes above and beyond to not only ensure optimal results but that the end client "gets it". I highly recommend his services.”
Karandeep Singh Badwal, The Medical Device Podcast
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“I have worked with Adam on several projects...
…relating to Medical Devices his regulatory experience and knowledge are exceptional and always up-to-date in the current climate of regulatory changes.”
Martin Coles, Operations Director - International Associates
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“Adam is a highly knowledgeable Medtech professional...
… who has a passion for the industry and its requirements. Adam hit the ground running supporting my requirements and is always dedicated. Adam brought his background and knowledge as part of a project in Supplier Quality working with critical partners including Six Sigma DMAIC and root cause analysis.”
QuMatthew Clark, European Supplier Quality Manager - CooperVision
“The PRRC role exists to ensure that regulatory responsibilities are properly understood and upheld. When that accountability is taken seriously, it strengthens the entire organisation.”
Adam Isaacs Rae, Founder
Need external PRRC support under MDR or IVDR?
We support medical device organisations requiring independent PRRC oversight.