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 provider of regulatory compliance solutions, focusing on the Medical Device, IVD, and Pharma industries. They offer expert services to ensure product safety and facilitate market access.

**Expertise & scope**
* PRRC (Person Responsible for Regulatory Compliance) services
* Quality Assurance (QA)
* Regulatory Affairs
* Coverage for the European Union (EU) market
* Services available in English, Dutch, and French

Additional information

Engaging GBA Key2Compliance for PRRC services involves leveraging their specialized expertise in navigating the complex regulatory landscapes of Medical Devices, IVDs, and Pharmaceuticals within the EU. Their focus on QA and regulatory affairs ensures that clients are well-equipped for market entry and ongoing compliance. Buyers can expect a professional engagement tailored to their specific product type and regulatory pathway, with communication facilitated in English, Dutch, or French.

Key Highlights

  • Specializes in PRRC services for Medical Device, IVD, and Pharma companies. Source
    “Specializing in PRRC services, QA, and regulatory affairs”
  • Provides regulatory compliance solutions for the EU market. Source
    “ensure product safety and market access.”
  • Offers services in English, Dutch, and French. Source
    “Languages: English, Dutch, French”

Certifications & Trust Signals

  • Provider name: GBA Key2Compliance Source
    “GBA Key2Compliance”
  • Coverage includes the EU market. Source
    “This role supports product safety, quality, and compliance in the EU market”

Buyer Snapshot

Best for
  • Medical Device, IVD, and Pharma companies seeking PRRC services
  • Companies targeting the EU market
How engagement typically works
  • Expert consultation on regulatory compliance
  • Support for QA and regulatory affairs
Typical deliverables
  • PRRC designation and support
  • Regulatory strategy and submissions
  • Quality system implementation guidance
Good to know
  • Best when requiring EU market access and compliance expertise.
HQ: Stockholm, SE
Languages: English, Dutch, French
Timezones: Europe/Brussels
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 (implied by Medical Device focus)
Supports IVDR
Yes (implied by IVD focus)
PRRC Qualification Summary
Expert regulatory compliance solutions, specializing in PRRC services.
Regulatory Experience
Expertise in Medical Device, IVD, and Pharma regulatory affairs.
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