We make complex things easier

Key2Compliance® offers complete and optimised solutions within Regulatory compliance.

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

Upcoming Courses

GMP Master Class

Apr 10
- Apr 11, 2024
Copenhagen, Denmark
QC-lab, Quality management and QA

Grundlæggende om GMP

May 2
Copenhagen, Denmark
General

Sterilization of Medical Devices

May 13
- May 17, 2024
Copenhagen, Denmark
Auditing/Inspection, Bioburden, ISO 11737, Sterilization, Validation

GMP for QC laboranter

May 16
QC-lab

Validering och kvalificering

May 21
- May 22, 2024
Stockholm, Sweden
Validation and Qualification

Medical Device Supplier Control and Outsourcing

May 28
- May 29, 2024
Copenhagen, Denmark
Quality management and QA

Design Controls for Medical Devices

May 29
- May 30, 2024
Copenhagen, Denmark
Design Control

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

Jun 11
- Jun 12, 2024
Copenhagen, Denmark
Computers/Software

GMP-krav på datoriserade system

Jun 11
- Jun 12, 2024
Stockholm, Sweden
Computers/Software

Strategic communication

Jun 12
- Jun 13, 2024
Copenhagen, Denmark
General, Quality management and QA

Auditor / Lead Auditor – Pharmaceuticals and Medical Devices

Jun 17
- Jun 19, 2024
Copenhagen, Denmark
Auditing/Inspection

Validation and qualification

Jun 18
- Jun 19, 2024
Copenhagen, Denmark
Validation and Qualification

Medical Device Quality Management Systems (QMS)

Jun 25
- Jun 27, 2024
Copenhagen, Denmark
Quality management and QA

Auditor/Lead Auditor – Läkemedel och medicinteknik

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

Medical Device Product Life Cycle

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

Presented by: Winta Woldai, Key2Compliance
Tags:
Biological Safety
Presented by: Maria Lindgren, Key2Compliance
Tags: Clinical evaluation

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.

Search

Cookies

For your best experience are we using cookies on this website.