A detailed examination of Laboratory-Developed Tests (LDTs) and In-House Devices

Zahra Madijahn Consultant, Regulatory Affairs The Power of Precision Medicine Laboratory-developed tests (LDTs), generally known as in-house devices, play a crucial role in diagnostic laboratories worldwide. Although both in-house devices and LDTs are created and utilized within a healthcare facility, the term “LDT” is generally used in a more specific context to refer to tests […]

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 […]

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 […]

Key2Compliance Collaborates with Uppsala Innovation Centre’s Knowledge Platform

Helena Dahlin

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!

Malin Truvé

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!

Oscar He

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 […]

Ny i rollen som RA – unik kurs i samarbete med Swedish Medtech

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 […]

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 […]

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