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How ISO13485 prepares your IVDR Quality System for audits and what it doesn't cover
Gain insights on how your compliance strategy can ensure your products meet the new requirements.
May 27th, 10.30-11.15 CET
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Dive into the challenges start-ups face and discover strategies to thrive.

May 15th - 11:00-11:45 AM CET
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Your MedTech CRO

– We navigate you right and fix what others can’t!

Let our team of industry experts step in, assess the situation, and guide your study to success.

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Ensure Full Compliance for Your Medical Device Software
We offer expert guidance in ensuring your software meets all necessary regulations, whether you're targeting the EU, US, or global markets.
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BioComp Bootcamp for Medical Devices
A FREE webinars series about Biocompatibility testing.
Feb 25 - 5 common myths debunked
Mar 25 - What tests fit your intended purpose?
Apr 28 - Retest or Not to Retest?
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We make complex things easier

GBA Key2Compliance offers complete and optimised solutions within Regulatory compliance.

MEDICAL DEVICE QA​

We can create processes and quality management systems that ensures the quality of your business and fully adapted to your organization. No more worries when the next audit appears.

BIOLOGICAL SAFETY

We help you plan, perform, and document the biological evaluation as well as other preclinical studies or the analytical performance evaluation, with the safety of patients in mind. We also perform toxicological risk assessments.

REGULATORY AFFAIRS​

Our team of regulatory specialists can support and guide you through the entire regulatory process for your product, from idea to market, in exactly the way you need it and in the specific market where you want it to be.

PHARMA QA​​

We provide quality assurance services related to GCP, GVP, GMP, GDP and GLP to help you fulfill all complex regulatory requirements and ensure the quality of your product

CLINICAL DEVELOPMENT​ - CRO

We are experts on clinical evaluations and investigations and will tailor the solution for the client’s product based on competence and experience, working as part of the client’s team.

TRAINING & COURSES​

We offer world-class training for Pharmaceutical and Medical Device companies. View our tailored program with in-house, on-demand and public courses.
More about us

Latest News & Events

Anna Östblom

Inside the Role of a Clinical Project Manager – Meet Anna Östblom

Free webinar May 15 2025 Why Most Device Start-up Companies Struggle to Survive – Ways to Thrive and Prosper!

Webinar: Why Most Device Start-up Companies Struggle to Survive – Ways to Thrive and Prosper!

Team meeting

How Strategic Knowledge Management Can Future-Proof Your GxP Organization

Medical Device equipment

Medical Device Classification Under MDR & IVDR: What Manufacturers Need to Know

Upcoming Courses

View Course calendar

GMP-krav på datoriserade system

Utbildning om de FDA och EU-regler och tolkningar som berör datoriserade och automatiserade system vid läkemedelstillverkning: 21 CFR 11 och EU GMP Annex 11
Apr 23
- Apr 24, 2025
Stockholm, Sweden
Computers/Software

Becoming a Regulatory Affairs Manager for Medical Devices

Get the knowledge and skills needed to lead the RA function at a medical device organization. Interpret and apply MDR, IVDR, and ISO 13485 effectively.
Apr 29
- Apr 30, 2025
Copenhagen, Denmark
Post market, Quality management and QA, Regulatory Affairs

Advanced Training in Biological Evaluation of Medical Devices

Learn how and when a biological evaluation, according to ISO 10993-1, should be performed. Understand the evaluation requirements and avoid common pitfalls!
May 14
Mölndal-Gothenburg, Sweden
Biocompatibility

Validation and qualification

Get in-depth knowledge of regulatory requirements regarding validation and qualification and their application in the pharmaceutical industry.

Jun 3
- Jun 4, 2025
Stockholm, Sweden
Validation and Qualification

Requirements to place Medical Device Software and Health Software on the market

Regulations and standards applicable to Medical Device Software: mobile apps, web apps, connected objects, and/or standalone software for diagnosis or planning.
Jun 11
- Jun 12, 2025
Copenhagen, Denmark
Computers/Software

GMP MasterClass

Get a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements in pharmaceutical production.
Jun 17
- Jun 18, 2025
Copenhagen, Denmark
QC-lab, Quality management and QA

Auditor/Lead Auditor – Läkemedel och medicinteknik

Denna specialanpassade utbildning ger dig de verktyg och färdigheter som krävs som Auditor eller Lead auditor inom läkemedels- och medicinteknisk industri.
Jun 24
- Jun 26, 2025
Stockholm, Sweden
Auditing/Inspection, Validation and Qualification

Basic Training in Biological evaluation of Medical Devices

Get fundamental knowledge to understand how and when a biological evaluation, according to ISO 10993-1, should be performed and avoid the most common pitfalls.
Sep 11
Mölndal-Gothenburg, Sweden
Biocompatibility

MDSAP – a global approach

Learn how to plan perform and report internal MDSAP audits as well as best practice and tools how to be prepared to undergo or perform MDSAP audits.
Sep 24
- Sep 25, 2025
Copenhagen, Denmark
Auditing/Inspection, Quality management and QA

Strategic communication

Get tools for clear communication about e.g. requirements and expectations in different situations. Be seen as a positive leader that inspires quality work.
Oct 7
- Oct 8, 2025
Copenhagen, Denmark
General, Quality management and QA

Auditor / Lead Auditor – Pharmaceuticals and Medical Devices

This tailor made training gives you the tools and skills required as Auditor or Lead Auditor in the Pharmaceutical and Medical Device industry.
Oct 21
- Oct 23, 2025
Copenhagen, Denmark
Auditing/Inspection

Cleaning validation of pharmaceutical process equipment

Learn details for all part of the global cleaning validation strategy in pharmaceutical activities. CGMP expectations, technical and regulatory updates.
Nov 5
- Nov 7, 2025
Copenhagen & Kolding, Denmark
Cleanrooms and cleaning, Sterile products, Validation and Qualification

Alfa Laval Live Cleaning-in-Place Experience & Site Tour

Experience Cleaning-in-Place (CIP) technology in action, incl. sustainability-focused cleaning processes, real-life trials, with experts in cleaning validation.
Nov 7
Kolding, Denmark
cleaning in place, Sterilization

Validering och kvalificering

Få fördjupade kunskaper om de regulatoriska kraven kring validering och kvalificering vid läkemedelstillverkning och hur de appliceras.
Nov 12
- Nov 13, 2025
TBC (Stockholm or Malmö, Sweden)
Validation and Qualification

Fördjupningskurs i CGMP för läkemedelstillverkning

En grundlig genomgång av viktiga delar i myndigheternas GMP- krav med fokus på tolkningar och hur kraven praktiskt appliceras i den dagliga verksamheten.
Nov 18
- Nov 19, 2025
TBC (Stockholm or Malmö, Sweden)
Quality management and QA

Medical Device Supplier Control and Outsourcing

Get tools and examples of best practice and learn how use the ‘Plan – Do – Check - Act approach’ to control and verify the performance of your suppliers.
Nov 19
- Nov 20, 2025
Copenhagen, Denmark
Quality management and QA
View Course calendar

Our Customers

Stories about how we support
our customers

"Navigating IVDR as a small company is tough—but the right collaboration makes all the difference."

"Thanks to thorough planning, hard work, strategic collaboration with both senior support from GBA Key2Compliance and support from our contract manufacturer, Prostatype successfully achieved IVDR certification—a major milestone for the company."

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DNA strings
Katarina SjöbergHead of RA/QA at
Prostatype Genomics
”When we needed a common training in root cause analysis for personnel from both engineers, manufacturing teamleaders, purchasers and auditors we chose GBA Key2Compliance to deliver it for us.
The training was a great success, not least because the flexibility from GBA Key2Compliance to adjust the sessions for our needs, the possibility to add real-world cases to train on between the sessions as well as a truly competent and inspiring trainer/teacher. I can definitely recommend them for your next training event!”
Sofie Nordhamren
Sofie Nordhamren Quality Director,
Envirotainer Engineering AB
"During a critical period for Flexicon, we received invaluable assistance from the consulting firm Key2Compliance, as we were without a Quality Manager for three months. /.../
I highly recommend GBA Key2Compliance to any company seeking professional, hands-on assistance during periods of increased need for quality management. "

READ MORE >
Flexicon FPC60 Filling
Birgitte Drøhse HøgedalQA Manager
Watson-Marlow Flexicon

Latest Webinars

We love to share our knowledge. Enjoy our webinar library to get the latest insights and expert knowledge.

View all webinars
Webinar: What about change management

What about Change Management

Presented by: Åsa Möllby, GBA Key2Compliance and Ella Wilhemsson, Medos
Tags: Medical Device QA

Webinar: New edition of the Toxicology standard ISO 10993-17 - what has changed

New edition of the toxicology standard ISO 10993-17:2023 - what has changed?

Presented by: Winta Woldai, GBA Key2Compliance

Tags: Biological Safety

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What's the point of the clinical evaluation?

Presented by: Maria Lindgren, GBA Key2Compliance
Tags: Clinical evaluation

Want to work at GBA Key2Compliance

Picture yourself at one of the best places to work, surrounded by teams and people who challenge you, support you, and inspire you to be extraordinary. Key2Compliance offers more than a job. We offer limitless opportunities to make a difference for our customers and improve patient safety. Join us today.

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