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Rent-a-PRRC

Your personal, dedicated, and instant PRRC

Scale your certified business at the touch of a button.

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What it is

Medical Device and In-vitro Diagnostics Medical Device manufacturers shall have a Person Responsible for Regulatory Compliance (PRRC) available. The PRRC’s task is to oversee and control the regulatory compliance of products released to the market, procedures, and processes.

For micro-, small- and medium-sized enterprises, the PRRC can be an external resource, which is permanently and continuously at disposal.

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What is included

Rent-a-PRRC includes the onboarding and actively acting as PRRC for Swiss entities. The service includes:

  • QMS review
  • Technical Documentation Review
  • Registration with the Competent Authority
  • Establishing Communication channels and training
  • Insurance coverage
  • Acting as PRRC, overseeing regulatory compliance of batch releases

How it works

The Rent-a-PRRC is a two-step approach to understand the QMS and documented product description and secondly, the operations as PRRC.

Set-up

The setup fee includes the QMS and Technical Document review, which is provided as a written report. There is no obligation to engage in a PRRC mandate after the initial review. The setup fee has to be paid in advance.

Operations

Acquired batch release credits can be used over 12 months after acquisition. No reimbursement of unused batch release credits is done. No minimum term for the service Rent-a-PRRC. The contract can be canceled any month, by end of the month.
 

Our Pricing

Your setup fee:

CHF 0

Your price for batch releases:

CHF 0

Receive your quote by email

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Please note that pricing may vary due to specifics of the products, documentation, manufacturing site, etc.

Rent-a-PRRC is a product of Avanti Europe.