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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Cleaning and
Sterilisation
processes Summit
Presentations by industry experts, workshops and networking
April 25-26, Copenhagen
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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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Is your Medical Device Software ready for MDR?
Get your software compliant soonest to be able to follow your plan.
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Your one-stop shop

Key2Compliance® offers complete and optimised solutions within Regulatory compliance. It doesn’t matter what your needs are – Quality Assurance, Regulatory Affairs, Biological Safety, Clinical Development or Training  – everything is within our expertise. 

We make complex things easier – all the way from idea to market.

More about us

Regulatory Affairs

Medical Device QA

Biological Safety

Clinical Development

Training & Courses

Pharma QA

Latest News & Events

Meet Gustav Sundström, one of our electrical safety experts!

News

Välkommen på inflyttningsmingel på GoCo House den 18:e april!

Events
Malin Truvé

Meet Malin Truvé, one of our Usability Evaluation experts!

News
Oscar He

Meet Oscar He, our Senior Consultant and Coordinating Manager for internal audits!

News

Meet our Coordinating manager for PRRC: Dalia Rhman!

News

Biological and Clinical Evaluations Conference for Medical Devices

Events

Upcoming Courses

View Course calendar

QA/RA Leader Medical Devices

Mar 21
- Mar 23, 2023
Amsterdam, Netherlands

Kvalitetssystemkrav för Medicinteknik

Apr 18
- Apr 20, 2023
Stockholm, Sweden

Cleaning and Sterilisation processes

Apr 25
- Apr 26, 2023
Copenhagen, Denmark

Grundlæggende om GMP

May 9
Copenhagen, Denmark

GMP-krav på datoriserade system

May 10
- May 11, 2023
Stockholm, Sweden

GMP for QC laboranter

May 11
Copenhagen, Denmark

Design Controls for Medical Devices

May 23
- May 24, 2023
Copenhagen, Denmark

Valid Statistical Techniques Made Easy

May 23
- May 25, 2023
Stockholm, Sweden

Strategic communication

May 24
- May 25, 2023
Copenhagen, Denmark

Validering og kvalificering

May 25
- May 26, 2023
Copenhagen, Denmark

Validering och kvalificering

May 31
- Jun 1, 2023
Stockholm, Sweden

Aseptic Manufacturing – Maintaining the validated state

May 31
- Jun 1, 2023
Copenhagen, Denmark

Auditor / Lead Auditor - Pharmaceuticals and Medical Devices

Jun 13
- Jun 15, 2023
Amsterdam, Netherlands
Pharmaceutical production

GMP Master Class

Jun 14
- Jun 15, 2023
Copenhagen, Denmark

GMP requirements for Computer Systems and Data Integrity

Jun 14
- Jun 15, 2023
Copenhagen, Denmark

Medical Device Quality Management Systems (QMS)

Jun 19
- Jun 21, 2023
Copenhagen, Denmark

Calendar
Public Courses

Compliance training from Key2Compliance® makes the knowledge easily accessible, applicable and makes it clear how the regulatory requirements affect your business.

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