ReguPartner
William Fry is a leading Irish corporate law firm with over 350 legal and tax professionals. They offer solutions-led legal advice across a wide range of practice areas, serving clients nationally and internationally.
Established in 1847, William Fry is a premier Irish corporate law firm renowned for its expertise and solutions-led approach. With over 350 legal and tax professionals and more than 500 staff, the firm excels in core practice areas including Corporate & M&A, Banking & Finance, Litigation & Investigations, and Asset Management & Investment Funds. Serving a diverse clientele of leading corporations, financial institutions, and government organizations, William Fry handles complex transactions and disputes with excellence. Their commitment to client success is evident in their deep experience and commercial know-how, ensuring they not only advise but also actively drive results. With offices in Dublin, Cork, London, New York, and San Francisco, and a global network, William Fry provides comprehensive legal and tax services. They are also Ireland's sole representative member of Taxand, a global network of tax advisors, further enhancing their international capabilities.
About
**Who they are**
ReguPartner is a MedTech consulting firm based in Stockholm, Sweden, dedicated to empowering medical device companies through complex regulatory demands. With over 15 years of combined experience in quality assurance and regulatory affairs, they focus on providing expert support to navigate MDR approval journeys safely and cost-effectively.
**Expertise & scope**
* CE-marking for medical devices, including Software as a Medical Device (SaMD)
* Person Responsible for Regulatory Compliance (PRRC) services
* Quality Management System (QMS) setup and compliance with ISO 13485, ISO 14971, and ISO 27001
* Gap analysis and continuous improvement initiatives
* Interim Quality or Regulatory leadership
* Technical documentation and Notified Body communication
* Audit preparation and support, including internal and external audits
* Risk management file creation and CAPA management
**Reputation / proof points**
* Over 15 years of combined experience in quality assurance and regulatory affairs.
* Successfully led the development and certification of medical device software under MDR.
* Focus on building compliant QMS, preparing technical documentation, and managing Notified Body submissions.
ReguPartner is a MedTech consulting firm based in Stockholm, Sweden, dedicated to empowering medical device companies through complex regulatory demands. With over 15 years of combined experience in quality assurance and regulatory affairs, they focus on providing expert support to navigate MDR approval journeys safely and cost-effectively.
**Expertise & scope**
* CE-marking for medical devices, including Software as a Medical Device (SaMD)
* Person Responsible for Regulatory Compliance (PRRC) services
* Quality Management System (QMS) setup and compliance with ISO 13485, ISO 14971, and ISO 27001
* Gap analysis and continuous improvement initiatives
* Interim Quality or Regulatory leadership
* Technical documentation and Notified Body communication
* Audit preparation and support, including internal and external audits
* Risk management file creation and CAPA management
**Reputation / proof points**
* Over 15 years of combined experience in quality assurance and regulatory affairs.
* Successfully led the development and certification of medical device software under MDR.
* Focus on building compliant QMS, preparing technical documentation, and managing Notified Body submissions.
Additional information
ReguPartner emphasizes a proactive approach to regulatory compliance, viewing Quality Management Systems as a company's backbone rather than a burden. Their mission is to guide clients through MDR approval efficiently, allowing them to concentrate on product development. They offer tailored support packages and interim leadership to address specific needs, from QMS setup to navigating Notified Body interactions. Engagement typically begins with understanding the client's specific regulatory challenges and product lifecycle stage.
Key Highlights
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Provides Person Responsible for Regulatory Compliance (PRRC) services.
Source
“Person Responsible for Regulatory Compliance (PRRC) services”
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Specializes in CE-marking for medical devices, including Software as a Medical Device (SaMD).
Source
“CE-marking for medical devices (incl. Software as Medical Device)”
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Offers QMS setup aligned with ISO 13485, ISO 14971, and ISO 27001 standards.
Source
“QMS setup (ISO 13485, ISO 14971, ISO 27001)”
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Provides interim Quality or Regulatory leadership.
Source
“Interim Quality or Regulatory leadership”
Certifications & Trust Signals
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Founded in Stockholm, Sweden.
Source
“ReguPartner ABAddress: 14170 Stockholm/Sweden]”
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Over 15 years of combined experience in quality assurance and regulatory affairs.
Source
“With over 15 years of combined experience in quality assurance and regulatory affairs, I’ve successfully led the development and certification of medical device software under the MDR.”
Buyer Snapshot
Best for
- Medical device companies seeking MDR/IVDR compliance support.
- Startups and established firms needing PRRC services.
- Companies requiring QMS implementation or improvement.
How engagement typically works
- Solutions-led legal and regulatory advice.
- Tailored support packages.
- Interim leadership roles.
Typical deliverables
- CE-marking strategy and execution.
- Technical documentation packages.
- ISO 13485 / ISO 14971 / ISO 27001 compliant QMS.
- PRRC services.
- Gap analysis reports.
- Audit preparation and support.
Good to know
- Best when requiring specialized MedTech regulatory expertise.
- Best when focused on EU market access.
HQ:
Dublin, IE
Languages:
English, Swedish
Timezones:
Europe/Stockholm
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
SE, 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:
Business hours
Device Classes Supported:
IVD
PRRC Qualification Summary:
ReguPartner offers Person Responsible for Regulatory Compliance (PRRC) services. They provide MedTech consulting to accelerate MDR approval, including services for Software as a Medical Device. Their expertise covers QMS setup (ISO 13485, ISO 14971, ISO 27001), gap analysis, and interim Quality or Regulatory leadership. They also offer QARA team mentoring and coaching.
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
The website mentions a 'Proven Process for Compliance Without Complexity' and 'Service Packages & Tailored Support' but does not detail specific onboarding steps.
Coverage Details
PRRC availability set to Custom with defined escalation path (seed summary).
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
The provider has over 15 years of combined experience in quality assurance and regulatory affairs, with a proven track record in leading the development and certification of medical device software under MDR.
Regulatory Experience
Over 15 years of combined experience in quality assurance and regulatory affairs, specifically in medical device software development and certification under MDR.
