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.
Published
Signal category
Customers & Market
Quote
“We 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.”
— Stefanie Wichansky|PRP Compliance team
Company
PRP Compliance
PRP provides Quality & Regulatory Experts to Medical Device companies
- Industry
- Business Consulting and Services
- Location
- Randolph, US
- Company size
- 26 employees
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.
Founded 2012