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 to navigate complex regulatory demands. With over 15 years of combined experience in quality assurance and regulatory affairs, they focus on providing expert support for MDR approval.
**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 according to ISO 13485, ISO 14971, and ISO 27001
* Gap analysis and continuous improvement initiatives
* Interim Quality or Regulatory leadership roles
* MDR/IVDR strategies
* Technical documentation preparation
* Notified Body communication and audit support
* Risk management file creation
* Addressing CAPAs and resolving deviations
**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.
* Experience includes building compliant QMS, preparing technical documentation, and managing submissions to Notified Bodies.
ReguPartner is a MedTech consulting firm based in Stockholm, Sweden, dedicated to empowering medical device companies to navigate complex regulatory demands. With over 15 years of combined experience in quality assurance and regulatory affairs, they focus on providing expert support for MDR approval.
**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 according to ISO 13485, ISO 14971, and ISO 27001
* Gap analysis and continuous improvement initiatives
* Interim Quality or Regulatory leadership roles
* MDR/IVDR strategies
* Technical documentation preparation
* Notified Body communication and audit support
* Risk management file creation
* Addressing CAPAs and resolving deviations
**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.
* Experience includes building compliant QMS, preparing technical documentation, and managing submissions to Notified Bodies.
Additional information
ReguPartner emphasizes that a Quality Management System should be the core of a company's operations, not an impediment. Their mission is to guide clients through their MDR approval journey efficiently and safely, allowing them to concentrate on product development. They offer tailored support packages and can provide interim leadership for quality or regulatory functions. Their approach aims to bring clarity and confidence to MedTech companies facing evolving regulatory landscapes.
Key Highlights
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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 dedicated Person Responsible for Regulatory Compliance (PRRC) services.
Source
“Person Responsible for Regulatory Compliance (PRRC) services”
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Provides Quality Management System (QMS) setup for ISO 13485, ISO 14971, and ISO 27001.
Source
“QMS setup (ISO 13485, ISO 14971, ISO 27001)”
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Supports MDR and IVDR strategies for regulatory compliance.
Source
“MDR / IVDR strategies”
Certifications & Trust Signals
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Founded in Stockholm, Sweden, with operations serving the EU market.
Source
“ReguPartner AB Address: 14170 Stockholm/Sweden]”
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Leverages 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
- Startups and established firms needing regulatory guidance
- Companies requiring PRRC services
How engagement typically works
- Consulting and advisory services
- Interim leadership placements
- Project-based support for specific regulatory tasks
Typical deliverables
- CE-marking strategy and execution
- Established Quality Management Systems (ISO 13485, ISO 27001)
- Technical documentation packages
- PRRC services
- Gap analysis reports
Good to know
- Best when clients are focused on MedTech product development and regulatory approval.
HQ:
Dublin, IE
Languages:
English, Swedish
Timezones:
Europe/Stockholm
Claim 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 responding to inquiries and booking requests as part of their service engagement.
Coverage Details
PRRC availability set to Custom with defined escalation path (seed summary).
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Implied through extensive experience in regulatory affairs and QMS development for medical devices under MDR.
Regulatory Experience
Over 15 years of combined experience in quality assurance and regulatory affairs, with specific success in medical device software certification under MDR.
Device Classes Supported
Not explicitly stated, but focus on MDR implies support for relevant classes.
