Company intelligence
PRP Compliance
PRP provides Quality & Regulatory Experts to Medical Device companies
About PRP Compliance
PRP Provides Quality & Regulatory Compliance Consultants/Contractors to Life Science Companies. Most Life Science leaders struggle to find Regulatory and Quality consultants/contractors especially at reasonable rates. PRP provides trusted professionals within your budget so you have peace of mind that your RA/QA work is off your plate. Our team is deeply experienced in FDA Regulatory Submissions (510Ks, INDs, NDAs, PMAs, De Novo, etc.), Global Product Registrations, QMS Implementation & Compliance, Medical Safety, Post-Marketing Surveillance, EU MDR and EU IVDR, Clinical Evaluation Reports, ISO 13485:2016, MDSAP and many other quality and regulatory challenges faced by our industry.
Verified activity
Signals from PRP Compliance
8 published signals
Research & Knowledge
PRP Compliance published the guide, FDA Inspection Preparation: A Comprehensive Guide, showing how organized systems, clear ownership, and inspection-ready documentation make readiness a day-to-day habit rather than a last-minute scramble.
Reported by Stefanie Wichansky
Customers & Market
PRP Compliance runs mock inspections and role-based training to build confidence, reduce risk, and strengthen your QMS.
Reported by Stefanie Wichansky
Customers & Market
PRP Compliance performed a targeted gap analysis and implemented corrective actions for a client with multiple observations in a prior inspection.
Reported by Stefanie Wichansky
Customers & Market
PRP Compliance developed a streamlined supplier qualification process and audit schedule for a client struggling with supplier control documentation.
Reported by Stefanie Wichansky
Research & Knowledge
PRP Compliance summarized the FDA's new QMSR in a 2-minute read focusing on operations, risk-based approach, supplier controls, supply chain transparency, software integration, cybersecurity, and ISO 13485-aligned documentation.
Reported by Stefanie Wichansky
Customers & Market
PRP Compliance helped a client implement a risk-based supplier evaluation matrix to reduce audit frequency without compromising quality.
Reported by Stefanie Wichansky
Customers & Market
PRP Compliance delivered tailored compliance roadmaps for other clients that integrated cybersecurity requirements and cut administrative burden to stay market-ready.
Reported by Stefanie Wichansky
Customers & Market
PRP Compliance helped a medical device team accelerate FDA submission readiness and avoid a costly market delay by deploying flexible resourcing and a focused end-to-end plan.
Reported by Stefanie Wichansky