Boumans Regulatory Consulting
Boumans Regulatory Consulting BV
Verified
High-end strategic regulatory consulting for European market entry, backed by 40 years of medical device expertise and practical authority-facing support.
Boumans Regulatory Consulting offers high end expertise in regulatory strategic consulting for companies interested in entering the European markets. 40 years of experience with medical devices, ranging from product development, via scientific studies, standardization, and a position as senior inspector for the Dutch competent authority, to consulting with global clients.
A very strong feature is the option to reserve a small budget that can be used to get detailed, strategically smart answers to regulatory questions. In other cases, companies have been assisted in their communication with the authorities, notified bodies, press, and others in various high-risk cases. The more traditional consulting projects are also possible, but Boumans Regulatory Consulting prefers to make companies do their work, instead of taking the regulatory work out of their hands.
This consulting comes under the motto:
A good pilot can land a plane in a storm
An excellent pilot knows when to fly around bad weather
About
Boumans Regulatory Consulting offers high end expertise in regulatory strategic consulting for companies interested in entering the European markets. 40 years of experience with medical devices, ranging from product development, via scientific studies, standardization, and a position as senior inspector for the Dutch competent authority, to consulting with global clients.
A very strong feature is the option to reserve a small budget that can be used to get detailed, strategically smart answers to regulatory questions. In other cases, companies have been assisted in their communication with the authorities, notified bodies, press, and others in various high-risk cases. The more traditional consulting projects are also possible, but Boumans Regulatory Consulting prefers to make companies do their work, instead of taking the regulatory work out of their hands.
This consulting comes under the motto:
A good pilot can land a plane in a storm
An excellent pilot knows when to fly around bad weather
A very strong feature is the option to reserve a small budget that can be used to get detailed, strategically smart answers to regulatory questions. In other cases, companies have been assisted in their communication with the authorities, notified bodies, press, and others in various high-risk cases. The more traditional consulting projects are also possible, but Boumans Regulatory Consulting prefers to make companies do their work, instead of taking the regulatory work out of their hands.
This consulting comes under the motto:
A good pilot can land a plane in a storm
An excellent pilot knows when to fly around bad weather
Additional information
Boumans Regulatory Consulting emphasizes practical, experience-based learning for PRRCs. Their training programs, including masterclasses and online courses, are designed to equip individuals with the confidence to navigate complex regulatory landscapes. They utilize real-world case studies and practice scenarios to bridge the gap between theoretical knowledge and practical application. The company also offers insights into the evolving role of the PRRC, addressing common challenges such as scapegoating and the importance of clear "rules of engagement" to prevent regulatory creep. Buyers can expect a focus on developing the PRRC role into a valuable asset for the organization, rather than a point of friction.
Key Highlights
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Principal consultant has over 30 years of experience in the medical device sector, including roles as a Senior Inspector and Senior Regulatory Consultant.
Source
“Ronald Boumans brings with him 30+ years of experience in the medical device sector.”
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Offers specialized PRRC training, masterclasses, and regulatory skills development focused on EU medical device regulations.
Source
“Welcome in the PRRC Academy, the home of the Training Services of Boumans Regulatory Consulting.”
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Training programs utilize real-world scenarios and case studies to enhance practical understanding and confidence.
Source
“This Masterclass consists of a full day of intense, live interaction. We will dive into the theory, discuss the practicalities of the templates that come with the training, and work with practice scenarios.”
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Covers key regulatory aspects including Article 15 of MDR/IVDR, MDCG guidance, liability, and communication with authorities.
Source
“The training will analyse Article 15 and MDCG guidance 2019-7 Rev.1 regarding the PRRC. But on top of that, other aspects will be addressed, like liability, insurance, and how a legal person can take its responsibilities and communicate about that.”
Certifications & Trust Signals
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Principal consultant 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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Extensive experience in various facets of the medical device field, including R&D, distribution, certification, and market surveillance.
Source
“Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation and consulting)”
Buyer Snapshot
Best for
- Manufacturers and authorized representatives seeking PRRC training and support.
- Companies needing to understand and implement PRRC responsibilities under MDR/IVDR.
- Individuals looking to develop practical regulatory compliance skills.
How engagement typically works
- Focused on practical, scenario-based training.
- Offers both online and in-person (open or in-house) training options.
- Emphasizes learning from real-world experience and peer interaction.
Typical deliverables
- PRRC Masterclasses
- Online PRRC starter courses
- Regulatory skills training sessions
- Guidance on PRRC appointment and role development
Good to know
- Best when buyers require specialized PRRC training and regulatory compliance expertise for the EU market.
HQ:
Schiedam, NL
Website:
boumansconsulting.com
Public email:
ronald@boumansconsulting.com
Phone:
+31 6 3928 0403
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Access:
Verified
Claim status:
Claimed
Services & Capabilities
Find PRRC Services | EU MDR/IVDR Providers & Quotes
Jurisdictions:
EU
Countries:
EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Response SLA:
72 hours
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
Training courses are designed to provide practical skills and confidence for PRRC roles, with starter courses involving online sessions and masterclasses offering full-day interactive sessions with practice scenarios.
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 with expertise in regulatory compliance for medical devices, as outlined in Article 15 of MDR/IVDR and MDCG guidance. Training focuses on developing this expertise through practical application and understanding of regulatory frameworks.
Regulatory Experience
Over 30 years of experience in the medical device sector, including roles as a Senior Inspector for medical technology and Senior Regulatory Consultant.
Device Classes Supported
Class I, IIa, IIb, III
