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IVDR compliance made simple – Expert guidance for your business
Are you ready to implement IVDR but don’t know where to start? We can help you become IVDR compliant.
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A local partner in a global market
Our team of specialists will support and guide you through the entire regulatory process, from idea to market.
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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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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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We make complex things easier

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​

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

Join our upcoming FREE Breakfastclub webinar!

Upcoming FREE Webinar: What about CAPA?

FREE Webinar: What’s the point of the Clinical Evaluation?

My trip to Ukraine with Smart Medical Aid – A Doctor’s journey

Upcoming Courses

View Course calendar

Fördjupningskurs i CGMP för läkemedelstillverkning

Nov 15
- Nov 16, 2023
Stockholm, Sweden
Quality management and QA

Grundlæggende om GMP

Nov 20
Copenhagen, Denmark
General

Sterilization of Medical Devices

Nov 20
- Nov 24, 2023
Copenhagen, Denmark
Auditing/Inspection, Bioburden, ISO 11737, Sterilization, Validation

EU Annex 1 – Manufacture of Sterile Medicinal Products

Nov 28
- Nov 29, 2023
Copenhagen, Denmark
Cleanrooms and cleaning, Sterile products

Auditor / Lead Auditor – Pharmaceuticals and Medical Devices

Nov 28
- Nov 30, 2023
Copenhagen, Denmark
Auditing/Inspection

Strategic communication

Dec 6
- Dec 7, 2023
Amsterdam, Netherlands
General, Quality management and QA

Medical Device Quality Management Systems (QMS)

Dec 6
- Dec 8, 2023
Copenhagen, Denmark
Quality management and QA

Validering och kvalificering

Dec 7
- Dec 8, 2023
Stockholm, Sweden
Validation and Qualification

Cleaning validation of pharmaceutical process equipment

Dec 12
- Dec 13, 2023
Copenhagen, Denmark
Cleanrooms and cleaning, Sterile products, Validation and Qualification

QA/RA Leader Medical Devices

Dec 13
- Dec 15, 2023
Copenhagen, Denmark
Quality management and QA, Regulatory Affairs

Auditor/Lead Auditor – Läkemedel och medicinteknik

Mar 13
- Mar 15, 2024
Stockholm, Sweden
Auditing/Inspection, Validation and Qualification

GMP-krav på datoriserade system

Mar 21
- Mar 22, 2024
Stockholm, Sweden
Computers/Software
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

Is your biological evaluation ready for MDR?

Presented by: Emma Pedersen and Kristina Fant
Tags: Biological Safety

The new irritation standard ISO 10993-23 for biological evaluation of medical devices

Presented by: Emma Pedersen
Tags: Biological Safety

Want to work at 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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