What you need know about electrical safety for medical devices according to the IEC 60601-series Electrical safety in medical devices is very important to ensure the safety of both patients and caregivers. The regulatory world of medical electrical devices can seem complex at times, especially with the transition to MDR and its new requirements. But, […]
Usability evaluations for better safety and design of medical devices Usability evaluations are connected to the risk management and is an important part of the technical documentation. Performing formative and summative evaluations will make sure that the user of the medical device can use it safely. Usability evaluations are not only important for the sake […]
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 […]
Key2Compliance Coordinating manager for PRRC explains what you need to know about the new required role of Person Responsible for Regulatory Compliance The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now […]
Let us introduce our newest colleagues: Linda Hansson, Tatiana Mattsson and Susanne Grimsby! 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. Linda Hansson, Consultant Clinical Development What will be your role at Key2Compliance? I will be part […]
Key2Compliance are happy to celebrate that our client, Atrogi, has announced first patient treated with its ATR-258 ß2-adrenoceptor agonist in their ongoing phase 1 study for the treatment of Type 2 Diabetes. Atrogi is an early-stage Swedish pharma company developing a novel solution for the treatment of Type 2 Diabetes. The trial is expected to be […]
Key2Compliance are excited to announce our move to GoCo House’s Office Hub in Gothenburg, Sweden. We moved into the Office Hub on February 1st 2023 and see GoCo as a strategic location for our continued expansion, offering opportunities to collaborate with partners and customers in an inspiring work environment. GoCo House’s Office Hub is a […]
Vill du känna dig säkrare i din roll inom Regulatory Affairs? Tillsammans med Swedish Medtech erbjuder vi nu en unik möjlighet med kompetensutveckling för dig som är ny i din roll! Under kursen får du kunskaper om Regulatory Affairs i de olika stegen från produktidé till färdig produkt och eftermarknadskrav. Föreläsare är Åse Ek och Anna […]
Key2Compliance can help companies in the pharmaceutical, medical device and in vitro diagnostic industry to avoid the pitfalls that regulatory requirements may present. With a strong offer in Quality Assurance, Key2Compliance can help clients reach the next level – all the way from development to commercial phase. For individual innovators or SMEs, it can be […]
Key2Compliance continues to grow, and the person that will ensure evolvement and improvement of our Quality Management System, QMS, is Anna-Karin Andermo – our new Quality Manager. Anna-Karin is already a familiar face at Key2Compliance where she has been active as senior regulatory affairs consultant for several years, helping our customers fulfilling regulations and making […]
