We can be your Biocompatibility Department

Do you require biocompatibility support at irregular intervals, without the need for a full-time employee? Would you like access to field experts precisely when you need them? Then choose us as your long-term partner! Led by Kristina Fant, Director of Biological Safety, our team serves as the biocompatibility department for many clients, deeply familiar with […]

A warm welcome to our new employees

Say hello to our newest colleagues: Claudia Dannehl, Maria de Matos and Afifa Trad! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. CLAUDIA DANNEHL, Senior Regulatory Affairs Consultant What will be your role at Key2Compliance? I will join Key2Compliance […]

Speaker announcement: Medical Device Product Life Cycle Conference

Exciting Announcement! Meet three of our speakers for the Medical Device Product Life Cycle Conference Join us on October 8-9 in Stockholm, Sweden for our international conference dedicated to navigating medical device regulations and standards. Our expert speakers will share invaluable insights and tools to simplify complexities in product safety and regulatory compliance. 🔹 Judith […]

Key2Compliance is a new Gold Sponsor for SmiLe

SmiLe is a leading venture hub that specializes in advancing life science startups from concept to commercialization. Their dynamic ecosystem connects entrepreneurs with seasoned business coaches, industry experts, investors, and sponsors, fostering a collaborative environment that fuels innovation and accelerates business growth. As part of our commitment to support the growth of small businesses and […]

The Importance of a Quality Management System (QMS) for Your Medical Device

Quality Management Systems QMS

Pär NeidenströmSenior consultant, Medical Device QA Dalia RhmanProduct manager PRRC, Medical Device QA The purpose of this article is to highlight the crucial role of the quality management system (QMS) for medical devices. Mainly by maintaining and improving patient safety and the product quality of the medical devices that are manufactured today. Of course, a […]

Join Us at Our ‘Medical Device Product Life Cycle’ Conference: Putting Patients First with Henrik Eriksson

At Key2Compliance, we believe in the power of impactful storytelling! We’re thrilled to announce Henrik Eriksson, a dialysis patient with years of firsthand experience, as our esteemed opening speaker at our “Medical Device Product Life Cycle” Conference in October. Henrik Eriksson’s insights offer a unique perspective, setting the stage for a conference filled with inspiration […]

Webinar – Elevate your Career: Insights on progression within MedTech Quality Assurance

Join us for a live webinar exploring the many opportunities within Quality Assurance for MedTech Professionals, hosted by industry experts from Key2Compliance Whether you are just starting out or looking for mid-career progression, this webinar will equip you with practical strategies and actionable steps to support a successful career in MedTech Quality Assurance. You’ll have […]

Four Notified Bodies Headline the Medical Device Product Life Cycle Conference 2024

Mark your calendars for October 8 and 9th, because Key2Compliance is bringing back the fantastic conference, “Medical Device Product Life Cycle”, to Stockholm! This time we’re excited to let you know that we’ve got an exceptional lineup of speakers from four Notified Bodies: Sharmila Gardner, Technical Documentation Manager & Head of UK Approved Body, from Intertek […]

Join our breakfast event tailored to address the different approaches and best practices in supplier control

Are you seeking to learn more about how to ensure effective supplier control and outsourcing of processes, and which control strategies you can apply? Join us for an exclusive breakfast session tailored to address the different approaches and best practices in supplier control! Our experts Åsa Möllby, Director of Medical Device QA, and Oscar He, Product manager and Senior Consultant, […]