IVDR – Overcoming challenges while establishing Regulatory strategy
By Julia Selmani Regulatory Affairs specialist, Key2Compliance AB Establishing a strategy for regulatory compliance for your company is a new IVDR requirement, defined in Article 10(8a) where the aspects to be addressed by manufacturer’s QMS are listed. Thought ISO 13485 does not explicitly include requirement for Regulatory strategy, it includes the requirement to incorporate regulatory […]
Join our international 2-day conference in Copenhagen on the 4-5th of October!
This is a must-attend conference for all medical device professionals dealing with biological and/or clinical evaluations, Clinical operations, QA/RA Managers, R&D managers and CEO:s. This conference will address biological and clinical evaluations from a risk perspective through a mixture of presentations from standard developers, notified bodies, test houses and device manufacturers. The first day will […]
We are happy to welcome our newest team members!
Say hello to our newest colleagues: Mikael Rapp, Mia Trustrup Larsen and Sara Falkenklint! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. MIKAEL RAPP, Chief Financial Officer What will be your role at Key2Compliance? I will be responsible for the […]
Welcome to join Innokas Medical and Key2Compliance´s Good Morning Meeting at Medicon Valley!
Optimal Regulatory and Design Development from Idea to Success of a Medical Device To succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow need to be considered. As the inventor or manufacturer of a medical device, a key success factor […]
Key2Compliance Collaborates with Uppsala Innovation Centre’s Knowledge Platform
We at Key2Compliance are happy to announce that we have formed a collaboration with Uppsala Innovation Centre (UIC), one of the leading business incubators in Sweden, to produce videos for its knowledge hub. We are honored to be given this opportunity to partner with UIC while sharing a common goal of providing start-ups and scale-ups […]
Meet Gustav Sundström, one of our electrical safety experts!
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, […]
Meet Malin Truvé, one of our Usability Evaluation experts!
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 […]
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 […]
A very warm welcome to our newest team members!
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 […]
Atrogi announces first patient treated with its ATR-258 ß2 adrenoceptor agonist
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 […]