GBA Key2Compliance
GBA Key2Compliance AB
GBA Key2Compliance offers expert regulatory compliance solutions for Medical Device, IVD, and Pharma companies. Specializing in PRRC services, QA, and regulatory affairs, they ensure product safety and market access.
GBA Key2Compliance is a full-service partner dedicated to simplifying complex regulatory compliance for Medical Device, IVD, and Pharmaceutical companies. With over 60 professionals, they provide expert consulting and specialized training, acting as a trusted partner to ensure a smooth journey from idea to market. As part of the GBA Group since January 2024, GBA Key2Compliance leverages expanded resources and global reach to offer comprehensive support across the entire value chain. This integration enhances their ability to ensure patient safety through optimized solutions, greater efficiency, and effective compliance with regulatory standards. Their core expertise includes Medical Device QA, Pharma QA, Regulatory Affairs, Clinical Development (CRO), Biological Safety, and training. They are particularly adept at providing external PRRC services for small and medium-sized enterprises (SMEs) under MDR 2017/745 and IVDR 2017/746, ensuring compliance and product safety for clients lacking in-house regulatory staff. GBA Key2Compliance has offices in Stockholm, Lund, Gothenburg, and Copenhagen, serving clients across the Nordics and beyond.
About
**Who they are**
GBA Key2Compliance is a specialized consultancy focused on regulatory compliance for Medical Device, IVD, and Pharma companies. They offer expert services to ensure product safety and facilitate market access.
**Expertise & scope**
* PRRC (Person Responsible for Regulatory Compliance) as a Service
* Quality Assurance (QA) services
* Regulatory Affairs support
* Coverage for the European Union (EU) market
* Services available in English, Dutch, and French
**Reputation / proof points**
* Specializes in navigating complex regulatory landscapes for medical devices, IVDs, and pharmaceuticals.
GBA Key2Compliance is a specialized consultancy focused on regulatory compliance for Medical Device, IVD, and Pharma companies. They offer expert services to ensure product safety and facilitate market access.
**Expertise & scope**
* PRRC (Person Responsible for Regulatory Compliance) as a Service
* Quality Assurance (QA) services
* Regulatory Affairs support
* Coverage for the European Union (EU) market
* Services available in English, Dutch, and French
**Reputation / proof points**
* Specializes in navigating complex regulatory landscapes for medical devices, IVDs, and pharmaceuticals.
Additional information
For companies seeking PRRC as a Service, GBA Key2Compliance focuses on providing dedicated regulatory expertise. Their approach ensures that clients maintain compliance with evolving EU regulations, particularly the MDR and IVDR. Engagement typically involves a thorough assessment of the client's product portfolio and regulatory strategy to tailor the PRRC services effectively. Deliverables often include regulatory documentation support, liaison with authorities, and ongoing monitoring of regulatory changes impacting the client's products.
Key Highlights
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Specializes in providing external PRRC services for EU micro and small enterprises.
Source
“External PRRC for small enterprises EU regulations allow micro and small enterprises (under 50 employees and with limited turnover) to meet PRRC requirements by having access to an external consultant or third-party provider”
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Offers a broad range of regulatory and quality assurance services including Design & Development, Risk Management, and Technical Documentation.
Source
“Regulatory Affairs Design & Development Due Diligence Electrical Safety Global Product Registration Post Market Surveillance Regulatory Strategy Risk Management Technical Documentation UK Representative”
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Part of the GBA Group since January 16, 2024, expanding global reach and service capabilities.
Source
“As of January 16, 2024, GBA Key2Compliance is proudly part of the GBA Group. This partnership brings numerous benefits, enhancing our service offerings and expanding our global reach.”
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Founded in the 1990s, with a merger in 2020, indicating significant experience in the field.
Source
“Symbioteq Kvalitet AB and Key2Compliance were founded as two independent companies during the 1990s. ... After several years of cooperation, the two companies merged in 2020 and formed a joint company called Key2compliance”
Certifications & Trust Signals
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Part of the GBA Group, a larger entity with extensive resources.
Source
“As of January 16, 2024, GBA Key2Compliance is proudly part of the GBA Group. This partnership brings numerous benefits, enhancing our service offerings and expanding our global reach.”
Buyer Snapshot
Best for
- Medical Device, IVD, and Pharma companies needing EU regulatory support
- Companies requiring outsourced PRRC services
How engagement typically works
- Consultative approach to regulatory challenges
- Tailored service packages based on client needs
Typical deliverables
- PRRC as a Service
- Quality Assurance documentation and processes
- Regulatory affairs strategy and execution
- Market access support for the EU
Good to know
- Best when clients require specialized expertise in EU medical device, IVD, or pharmaceutical regulations.
HQ:
Stockholm, SE
Languages:
English, Dutch, French
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
SE, GB, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 3,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Custom
Device Classes Supported:
IVD
PRRC Qualification Summary:
To qualify as a PRRC, an individual must have a relevant university degree—such as in law, medicine, pharmacy, engineering, or a scientific discipline—and at least one year of experience in regulatory affairs or quality management for medical devices or IVDs. Alternatively, a candidate without the required educational background may qualify by having four years of professional experience in regulatory affairs or quality management systems related to medical devices. GBA Key2Compliance offers PRRC services specifically designed for organizations with fewer than 50 employees. For manufacturers with fewer than 50 employees, GBA Key2Compliance can directly assume the PRRC role in compliance with Article 15 of MDR 2017/745 and IVDR 2017/746. This includes providing qualified personnel who meet all regulatory requirements and ensuring the company’s full commitment to patient safety and regulatory obligations.
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).
Device Classes Supported
Class I, IIa, IIb, III (implied by Medical Device, IVD focus)
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Expert regulatory compliance solutions, specializing in PRRC services.
Regulatory Experience
Expertise in Medical Device, IVD, and Pharma regulatory affairs.
