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 support for companies navigating complex regulatory landscapes.
**Expertise & scope**
- PRRC (Person Responsible for Regulatory Compliance) as a Service
- Quality Assurance (QA) services
- Regulatory Affairs support
- Ensuring product safety and facilitating market access
- Coverage for the EU market
**Reputation / proof points**
- Services offered in English, Dutch, and French
GBA Key2Compliance is a specialized consultancy focused on regulatory compliance for Medical Device, IVD, and Pharma companies. They offer expert support for companies navigating complex regulatory landscapes.
**Expertise & scope**
- PRRC (Person Responsible for Regulatory Compliance) as a Service
- Quality Assurance (QA) services
- Regulatory Affairs support
- Ensuring product safety and facilitating market access
- Coverage for the EU market
**Reputation / proof points**
- Services offered in English, Dutch, and French
Additional information
GBA Key2Compliance focuses on providing essential regulatory functions, particularly the PRRC role, to ensure ongoing compliance for medical devices, IVDs, and pharmaceuticals within the EU. Their service is designed to support manufacturers who may not have in-house expertise or capacity to meet these stringent requirements. Engaging with GBA Key2Compliance typically involves defining the scope of regulatory support needed, establishing clear communication channels, and ensuring all necessary documentation is in place for effective oversight and compliance management.
Key Highlights
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Offers 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, instead of hiring an in-house specialist.”
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Provides a wide range of regulatory and quality services including Design & Development, Risk Management, and Global Product Registration.
Source
“Regulatory Affairs Design & Development Due Diligence Electrical Safety Global Product Registration Post Market Surveillance Regulatory Strategy Risk Management Technical Documentation”
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Part of the GBA Group since January 2024, expanding global reach and comprehensive support.
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.”
Certifications & Trust Signals
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Founded in the 1990s, with companies merging in 2020.
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”
Buyer Snapshot
Best for
- Medical Device, IVD, and Pharma companies needing EU regulatory compliance support.
- Companies seeking external PRRC services to ensure market access and product safety.
How engagement typically works
- Retainer-based PRRC services.
- Consultative approach to QA and regulatory affairs.
Typical deliverables
- Appointed PRRC for EU market.
- Regulatory strategy and submissions.
- Quality system implementation and maintenance.
Good to know
- Best when requiring specialized expertise for EU MDR/IVDR compliance.
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
Founded in the 1990s, with expertise in Regulatory Affairs and Quality Management for Medical Devices and IVDs.
