Outsourcing Internal Audits in MedTech: Strategic Advantage or Regulatory Risk?
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the medical device industry, internal audits are a vital part of maintaining compliance, ensuring product safety, and preparing for regulatory inspections. But as companies face increasing complexity, limited resources, and the pressure of unannounced audits, many are asking: Is it acceptable to outsource […]
GBA Key2Compliance supports BOHUS with comprehensive CRO services
GBA Key2Compliance Enhances Quality Assurance, Regulatory Compliance, and Clinical Investigation for BOHUS At GBA Key2Compliance, we take pride in our role as the primary CRO for BOHUS, a Swedish company dedicated to producing high-quality hyaluronic acid (HA) products. Specializing in ophthalmics, aesthetics, and orthopedics, BOHUS extends its market reach to over 60 countries in the […]
FINAL CALL: Only 6 Days Left! Join us for the Medical Device Product Life Cycle Conference
Don’t miss our international conference tailored to navigating the complexities of medical device regulations and standards. Why Attend? Gain invaluable knowledge from top industry leaders who will simplify complex processes and provide essential tools for success. Whether you’re in Quality, Regulatory, Design & Development, Clinical/Performance Evaluations, or Post-Market Surveillance, this conference is essential for staying […]
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 […]
Navigating Medical Device Regulations – Insights from Our Danish Consultants
Cecilie Bengtsen, Mia Trustrup Larsen, and Nadia Ragnvald Caspersen Key2Compliance has in the past two years expanded its Nordic presence with a dedicated team of regulatory compliance consultants in Denmark. The expansion is timely, given the increasingly stringent compliance requirements for medical devices introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic […]
Meet Oscar He, our Senior Consultant and Coordinating Manager for internal audits!
Internal audits – an opportunity to improve medical devices Internal audits are an important activity for medical device manufacturers. They are not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. Oscar He is coordinating the […]
Thank you for attending our conference!
Key2Compliance this week hosted for the first time the Medical Device Product Life Cycle Conference, and we could not be any happier! Thanks to all the committed participants, speakers, and exhibitors for two fantastic days and for making this a success. Also thank you to our excellent moderator, Magnus Fyrfalk, who took on the task […]
Welcome to Our Newest Team Members!
Our team keeps growing! We are very happy to welcome our newest colleagues Johan Grahn, Jonas Jägerback and Lars Mentzer on board. They are joining forces with us to help continue doing what we love to do: make complex things easier – all the way from idea to market. JOHAN GRAHN, Senior Consultant Regulatory Affairs What […]
Welcome to the team!
Welcome our newest rockstars to Key2Compliance, Heléne Lindegren, Malin Borg, Dalia Rhman och David Dahi. Four individuals who are joining us and no doubt will have a huge impact on their clients and teams! Welcome to the team! HELÉNE LINDEGREN, Business & Contract Manager What will be your role at Key2Compliance? My role at Key2Compliance […]
Welcome our next speaker – Åse Ek!
Medical Device Product Life Cycle – a conference for QA & RA professionals! Let’s welcome our next speaker in line , Ase Ek, Senior Consultant and Trainer at Key2Compliance to our Medical Device Product Life Cycle conference!! 𝗕𝗲𝗶𝗻𝗴 𝘁𝗵𝗲 ‘𝗣𝗲𝗿𝘀𝗼𝗻 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗹𝗲 𝗳𝗼𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲’ – 𝗶𝘀 𝘁𝗵𝗶𝘀 𝗶𝗻 𝗳𝗮𝗰𝘁 𝗮 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘁𝗿𝗼𝗹, 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗮𝗳𝗳𝗮𝗶𝗿𝘀, 𝗼𝗿 […]