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Medical Device Product Life Cycle Conference
Boosting medtech knowledge together!
October 8-9 in Stockholm, Sweden
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Your guide in clinical trials
We offer tailored solutions and support in regulatory processes
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Knowledge is the
key 2 success!
Empower your team with our trainings and courses.
Course Program
Are you ready for the next audit?
We will help you create efficient processes and quality management systems, ensuring the quality of your operations.
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Classify your Medical Device products with our free AI-service
Simplify the complex process of classifying your products with our AI-Classifier and take the first step towards Medical Device classification.
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eTMF - a clinical investigation documentation system
Our user-friendly, cost-effective, and regulatory compliant eTMF system helps in making your clinical studies easier.
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The key 2 success?
We will help you ensure the quality of your products and compliance with GXP requirements using the right people, in the right place, at the right time.
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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

FINAL CALL: Only 6 Days Left! Join us for the Medical Device Product Life Cycle Conference

Join Us: The Medical Device Product Life Cycle Conference – 8-9 October

Join Us at NLS Days on September 18-19!

Meet our new Director of Sales – Anders Jeppsson

Upcoming Courses

View Course calendar

Auditor/Lead Auditor – Läkemedel och medicinteknik

Sep 24
- Sep 26, 2024
Stockholm, Sweden
Auditing/Inspection, Validation and Qualification

Medical Device Product Life Cycle Conference

Oct 8
- Oct 9, 2024
Stockholm, Sweden
MDR, Quality management and QA, Regulatory Affairs

Cleaning validation of pharmaceutical process equipment

Oct 22
- Oct 23, 2024
Copenhagen, Denmark
Cleanrooms and cleaning, Sterile products, Validation and Qualification

Medical Device Supplier Control and Outsourcing

Nov 6
- Nov 7, 2024
Copenhagen, Denmark
Quality management and QA

Validering och kvalificering

Nov 6
- Nov 7, 2024
Stockholm, Sweden
Validation and Qualification

GMP for ATMP – Flemingsberg

Nov 7
Innovation Station Flemingsberg, Huddinge, Sweden
ATMP, General, GMP

Strategisk kommunikation – Utveckla din roll som QA

Nov 11
- Nov 12, 2024
Stockholm, Sweden
Quality management and QA

GMP-krav på datoriserade system

Nov 12
- Nov 13, 2024
Stockholm, Sweden
Computers/Software

Sterilization of Medical Devices

Nov 18
- Nov 22, 2024
Copenhagen, Denmark
Auditing/Inspection, Bioburden, ISO 11737, Sterilization, Validation

MDSAP – a global approach

Nov 19
- Nov 20, 2024
Auditing/Inspection, Quality management and QA

Design and development of Medical Devices

Nov 26
- Nov 27, 2024
Copenhagen, Denmark
Design Control

Effective root cause investigation for the Life Sciences

Dec 2
- Dec 3, 2024
Copenhagen, Denmark
CAPA, Quality management and QA

Auditor / Lead Auditor – Pharmaceuticals and Medical Devices

Dec 4
- Dec 6, 2024
Copenhagen, Denmark
Auditing/Inspection

Strategic communication

Dec 4
- Dec 5, 2024
Copenhagen, Denmark
General, Quality management and QA

Learning, Knowledge Management, and Impact

Dec 5
- Dec 6, 2024
Copenhagen, Denmark
General, Quality management and QA

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

Dec 10
- Dec 11, 2024
Copenhagen, Denmark
Computers/Software

QA/RA Leader Medical Devices

Dec 17
- Dec 18, 2024
Copenhagen, Denmark
Quality management and QA, Regulatory Affairs
View Course calendar
Jan Hellqvist, CEO

“Our most important asset is our dedicated staff. Our team consists of specialists from all over the world, with long and broad expertise in all aspects of the development of medical devices and in vitro diagnostics. It is the team that makes the difference!”

Jan Hellqvist – CEO

Latest Webinars

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

View all webinars
What about change management

What about Change Management

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

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

Presented by: Winta Woldai, GBA Key2Compliance

Tags: Biological Safety

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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GBA Key2Compliance
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