PRRC Academy

PRRC Academy

Welcome in the PRRC Academy, the home of the Training Services of Boumans Regulatory Consulting.


New trainings curriculum for 2024
PRRC announcements

New trainings curriculum for 2024

2022, November 26

Our curriculum

Our courses

2024 02-19 & 26 |  In-house manufacturer PRRC starter training
PRRC Academy

2024 02-19 & 26 | In-house manufacturer PRRC starter training

2024 03-05 & 12 | In-house authorized representative PRRC training
PRRC Academy

2024 03-05 & 12 | In-house authorized representative PRRC training

2024 04-23 & 30 | In-house authorized representative PRRC training
PRRC Academy

2024 04-23 & 30 | In-house authorized representative PRRC training

2024 05-14 & 21 | Outsourced manufacturer PRRC
PRRC Academy

2024 05-14 & 21 | Outsourced manufacturer PRRC

2024 04-9 & 16 | Outsourced manufacturer PRRC
PRRC Academy

2024 04-9 & 16 | Outsourced manufacturer PRRC

2024 02-20 & 27 | Outsourced manufacturer PRRC
PRRC Academy

2024 02-20 & 27 | Outsourced manufacturer PRRC

2024 04-23 & 30 |  In-house manufacturer PRRC starter training
PRRC Academy

2024 04-23 & 30 | In-house manufacturer PRRC starter training

2024 03-19 & 26 |  In-house manufacturer PRRC starter training
PRRC Academy

2024 03-19 & 26 | In-house manufacturer PRRC starter training

Agnieszka Swiatek – Regulations Manager @Byteflies
Endorsements

Agnieszka Swiatek – Regulations Manager @Byteflies

Over 1,000 notified body applications per month. Will your device be among them?
Tip of the week

Over 1,000 notified body applications per month. Will your device be among them?

Melissa Finocchio, Chief Regulatory Officer at SOPHiA Genetics
Endorsements

Melissa Finocchio, Chief Regulatory Officer at SOPHiA Genetics

Regulation (EU) 2023/607 MDR transitional arrangements for Class III and Class IIb, implantable devices
Tip of the week

Regulation (EU) 2023/607 MDR transitional arrangements for Class III and Class IIb, implantable devices

Regulation 2023/607 MDR transitional arrangements for Class IIa and Class IIb, non-implantable devices
Tip of the week

Regulation 2023/607 MDR transitional arrangements for Class IIa and Class IIb, non-implantable devices

MDR Article 120 and 122 consolidated
Tip of the week

MDR Article 120 and 122 consolidated

MDR Amendment Regulation (EU) 2023/607
Longread

MDR Amendment Regulation (EU) 2023/607

PRRC scenario
Tip of the week

PRRC scenario

Feasibility check for the applicability of MDR Article 97
Tip of the week

Feasibility check for the applicability of MDR Article 97

Quick due diligence checklist non-integral DDC
Tip of the week

Quick due diligence checklist non-integral DDC

Q
Tip of the week

Q

Quick due diligence checklist integral DDC
Tip of the week

Quick due diligence checklist integral DDC

Drug-device combinations need a specific MD department within a pharma company
Tip of the week

Drug-device combinations need a specific MD department within a pharma company

New trainings curriculum for 2024
PRRC announcements

New trainings curriculum for 2024

Regulatory skills training
Training type descriptions

Regulatory skills training

PRRC online starter training
Training type descriptions

PRRC online starter training

Case: Missed mixed status devices in a system
Tip of the week

Case: Missed mixed status devices in a system

Devices that are used together, components, accessories, systems, procedure packs, and the rest…
Tip of the week

Devices that are used together, components, accessories, systems, procedure packs, and the rest…

Article 54/59 derogation – yes, it can be done, but I rather suggest you should try not having to depend on it…
Tip of the week

Article 54/59 derogation – yes, it can be done, but I rather suggest you should try not having to depend on it…

Recognizing early warnings of approaching problems
Tip of the week

Recognizing early warnings of approaching problems

Check your consistency, your notified body will do that for sure
Tip of the week

Check your consistency, your notified body will do that for sure

Article 16 – some loose ends in the Regulations…
Tip of the week

Article 16 – some loose ends in the Regulations…

Dvora Galli Tal, VP Quality & International Regulatory, Active Implants
Endorsements

Dvora Galli Tal, VP Quality & International Regulatory, Active Implants

Article 16, where ends the responsibility of the manufacturer?
Tip of the week

Article 16, where ends the responsibility of the manufacturer?

Elena Kyria, CEO and founder of Elemed, MDR Community Leader | RAPS | Executive Headhunter | Podcast Host
Endorsements

Elena Kyria, CEO and founder of Elemed, MDR Community Leader | RAPS | Executive Headhunter | Podcast Host

How to create a justification for a PRRC
Templates and how to’s

How to create a justification for a PRRC

Regulation (EU) 2023/607 allows the notified bodies more time for certification
Featured

Regulation (EU) 2023/607 allows the notified bodies more time for certification

UDI in the case of systems and procedure packs
Tip of the week

UDI in the case of systems and procedure packs

Dorthe Wallin, QA/RA manager at Cortex Technology ApS, Danmark
Endorsements

Dorthe Wallin, QA/RA manager at Cortex Technology ApS, Danmark

The strategic importance of the Basic UDI-DI
Tip of the week

The strategic importance of the Basic UDI-DI

Grouping Device Families: the Basic UDI-DI
Tip of the week

Grouping Device Families: the Basic UDI-DI

Avoiding costly mistakes: implement first, develop later
Tip of the week

Avoiding costly mistakes: implement first, develop later

CEO’s and General Managers: selecting a PRRC is not a popularity contest
Tip of the week

CEO’s and General Managers: selecting a PRRC is not a popularity contest

Government response to public consultation on the new UK medical devices regulations
Tip of the week

Government response to public consultation on the new UK medical devices regulations

MDCG’s lifeline for escaping the MDR certification bottleneck
Tip of the week

MDCG’s lifeline for escaping the MDR certification bottleneck

Erik Vollebregt of Axon Lawyers, Amsterdam
Endorsements

Erik Vollebregt of Axon Lawyers, Amsterdam

The difference between PMS and PMCF in one minute
Tip of the week

The difference between PMS and PMCF in one minute

When is UKCA marking necessary?
Tip of the week

When is UKCA marking necessary?

Preparing for UKCA marking of medical devices
Tip of the week

Preparing for UKCA marking of medical devices

Cathi Crist, Sr. Medical Device Cross Functional leader at Intuitive Surgical Inc.
Endorsements

Cathi Crist, Sr. Medical Device Cross Functional leader at Intuitive Surgical Inc.

Affordable high end consulting
Expert Services

Affordable high end consulting

Outsourcing PRRC
Expert Services

Outsourcing PRRC

Borderline and classification support
Expert Services

Borderline and classification support

Notified body search and selection
Expert Services

Notified body search and selection

Emergency assistance
Expert Services

Emergency assistance

EUDAMED and UDI
Expert Services

EUDAMED and UDI

Mergers & acquisitions support
Expert Services

Mergers & acquisitions support

Justification of product status and risk class
Tip of the week

Justification of product status and risk class

Last minute placing on the market under ‘old’ rules
Tip of the week

Last minute placing on the market under ‘old’ rules

Coming soon
Longread

Coming soon