Boumans Regulatory Consulting
Boumans Regulatory Consulting BV
Boumans Regulatory Consulting offers expert regulatory compliance services for medical devices in the European market. They specialize in PRRC training, masterclasses, and adapting to new regulations like the Product Liability Directive.
Boumans Regulatory Consulting brings over 30 years of in-depth experience in complex compliance cases, ensuring companies can confidently make medical devices available on European markets. They provide specialized training and consulting services, particularly focusing on the role of the Person Responsible for Regulatory Compliance (PRRC) under MDR and IVDR. Their offerings include the PRRC Academy, featuring masterclasses, online training, and regulatory skills development. These programs are designed to equip professionals with practical experience, covering essential topics like Article 15 of the MDR/IVDR, MDCG guidance, liability, and effective communication with authorities. The training emphasizes learning from real-world scenarios and developing the PRRC role into a valuable asset for organizations. Boumans Regulatory Consulting also helps businesses prepare for evolving regulatory landscapes, such as the upcoming Product Liability Directive (EU) 2024/2853. They assist in ensuring technical documentation is complete and compliant, enabling companies to navigate new liability rules and maintain full control over their processes. Their approach emphasizes out-of-the-box thinking to address regulatory challenges effectively.
About
**Who they are**
Boumans Regulatory Consulting, founded in 2022 by Ronald Boumans, offers specialized regulatory compliance services for medical devices, particularly focusing on the European market. With over 30 years of experience in the medical device sector, Ronald Boumans brings a unique, multi-angled perspective to regulatory challenges.
**Expertise & scope**
* Expertise in EU medical device regulations, including MDR and IVDR.
* Specializes in training and consulting for the Person Responsible for Regulatory Compliance (PRRC) role.
* Offers masterclasses, online courses, and regulatory skills training designed to build practical experience.
* Covers adapting to new regulations such as the Product Liability Directive.
* Services include PRRC training, masterclasses, and adapting to new regulations.
**Reputation / proof points**
* Founded in 2022.
* Ronald Boumans has over 30 years of experience in the medical device sector, including roles as a product designer, distributor, inspector for the Dutch Healthcare Inspectorate, and senior regulatory consultant.
Boumans Regulatory Consulting, founded in 2022 by Ronald Boumans, offers specialized regulatory compliance services for medical devices, particularly focusing on the European market. With over 30 years of experience in the medical device sector, Ronald Boumans brings a unique, multi-angled perspective to regulatory challenges.
**Expertise & scope**
* Expertise in EU medical device regulations, including MDR and IVDR.
* Specializes in training and consulting for the Person Responsible for Regulatory Compliance (PRRC) role.
* Offers masterclasses, online courses, and regulatory skills training designed to build practical experience.
* Covers adapting to new regulations such as the Product Liability Directive.
* Services include PRRC training, masterclasses, and adapting to new regulations.
**Reputation / proof points**
* Founded in 2022.
* Ronald Boumans has over 30 years of experience in the medical device sector, including roles as a product designer, distributor, inspector for the Dutch Healthcare Inspectorate, and senior regulatory consultant.
Additional information
Boumans Regulatory Consulting emphasizes practical, experience-based learning for PRRCs. Their training programs, including masterclasses and online courses, are designed to move beyond theory by incorporating real-world scenarios and case studies. This approach aims to equip PRRCs with the confidence and skills to navigate complex regulatory landscapes, manage potential liabilities, and effectively communicate with authorities. The company also highlights the importance of understanding the nuances of the PRRC role, differentiating it from auditing, and developing clear 'rules of engagement' to proactively address regulatory challenges.
Key Highlights
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Offers specialized training and masterclasses for the PRRC role, addressing both MDR and IVDR requirements.
Source
“Welcome in the PRRC Academy, the home of the Training Services of Boumans Regulatory Consulting.”
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Provides regulatory skills training focused on interpreting and applying regulations to specific situations.
Source
“All trainings enable staff feeling confident when doing these interpretations, always within the context of the applicable requirements.”
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Founded by Ronald Boumans, who has over 30 years of experience in the medical device sector, including roles as a senior inspector and regulatory consultant.
Source
“Ronald Boumans brings with him 30+ years of experience in the medical device sector.”
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Focuses on practical application through real-world scenarios and case studies in training.
Source
“The scenarios used for practice are based on real cases, so students can learn from experience from other PRRCs.”
Certifications & Trust Signals
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Ronald Boumans previously served as a Senior Inspector for medical technology at the Dutch Healthcare Inspectorate.
Source
“worked 10+ years as an Inspector for the Dutch Healthcare Inspectorate, the Competent Authority for The Netherlands”
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Ronald Boumans has extensive experience as a Senior Regulatory Consultant, including nine years at Emergo Europe Consulting B.V.
Source
“worked for nine years as a senior regulatory consultant for Emergo Europe Consulting B.V..”
Buyer Snapshot
Best for
- Manufacturers and authorized representatives needing PRRC support and training.
- Companies seeking to understand and implement EU medical device regulations (MDR/IVDR).
- Individuals aiming to develop expertise as a PRRC.
How engagement typically works
- Training-focused (masterclasses, online courses, skills training).
- Consulting on regulatory compliance.
- Practical, scenario-based learning.
Typical deliverables
- PRRC training programs.
- Masterclasses on PRRC roles and responsibilities.
- Regulatory skills development workshops.
- Guidance on adapting to new regulations.
Good to know
- Best when focused on EU market compliance.
- Best when seeking practical, experience-driven regulatory training.
HQ:
Schiedam, NL
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Starting from:
EUR 1,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Custom
Device Classes Supported:
Class IIa, Class IIb, Class III
PRRC Qualification Summary:
Boumans Regulatory Consulting offers PRRC training and services, emphasizing practical experience over pure theory. Their PRRC Academy provides online courses, masterclasses, and regulatory skills training designed to equip individuals with the necessary expertise and confidence to manage regulatory compliance. The training covers Article 15 of MDR/IVDR, MDCG guidance, liability, insurance, and the appointment and development of the PRRC role. They focus on helping PRRCs become valuable assets to companies, avoiding common pitfalls, and effectively communicating with authorities. The courses are based on real-world scenarios and aim to prepare PRRCs for audits and management expectations, ensuring they can independently perform their role and provide valuable regulatory opinions.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Intake → scope & device class mapping → responsibilities matrix → workflow setup → ongoing PRRC coverage
Coverage Details
PRRC availability set to Custom with defined escalation path (seed summary).
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
The PRRC role requires a person responsible for regulatory compliance, with training and experience in medical devices. Specific qualifications are detailed in MDCG guidance 2019-7 Rev. 1.
Regulatory Experience
Over 30 years of experience in the medical device sector, encompassing R&D, distribution, certification, market surveillance, policy making, and consulting. Specific experience includes 10+ years as a Senior Inspector for medical technology and nine years as a Senior Regulatory Consultant.
