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Navigating Medical Device Regulations – Insights from Our Danish Consultants

As medical device regulations evolve, expert guidance becomes increasingly crucial. Key2Compliance support medical device and IVD manufacturers throughout the lifecycle, ensuring compliance and that applicable regulations are met. In this article we become acquainted with some of our Danish consultants who are well-equipped to help startups and established companies navigate the complexities.

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 Regulation (IVDR). The requirements have significantly raised the bar for safety and performance requirements, demanding more comprehensive documentation, reclassification of products, and adaptation to emerging technologies. Denmark is home to a thriving medical device sector, making it a crucial hub for addressing the new challenges these regulations present.

Key2Compliance’s team of experts in Denmark offers tailored regulatory strategies, guiding manufacturers through the certification process and ensuring compliance with the new standards. This includes risk management, compliance planning, and ongoing support to adapt to regulatory changes. This expansion is a strategic move to support medical device manufacturers in the Nordics, simplifying the compliance process and enabling them to meet the challenges of the new regulatory landscape efficiently and effectively.

Meet Some of Key2Compliance Danish Team of Experts
The Danish team at Key2Compliance has extensive experience in guiding medical device companies, especially startups, through the complex certification process of medical devices. Take a moment and meet three of our experts who bring extensive experience and insights;

  • Mia Trustrup Larsen, a QA/RA consultant with over a decade of experience in the medical device industry, brings a wealth of knowledge in Quality Assurance and Regulatory Compliance.
  • Cecilie Bengtsen, a Senior Regulatory Affairs Consultant, leverages her background in biochemistry and pharmaceuticals, along with 15 years of experience in regulatory compliance, to provide comprehensive consulting services.
  • Nadia Ragnvald Caspersen, a Medical Device Quality Assurance Consultant, combines her laboratory and research experience with over 15 years in quality assurance and lead auditing to offer in-depth guidance.

Expertise Beyond Individual Consultants
Nadia Ragnvald Caspersen emphasizes the collective strength of Key2Compliance: “You don’t just hire the expertise of one consultant, you hire the services of a powerhouse; a knowledge bank.” Key2Compliance approach ensures that clients receive well-rounded support in building strong technical files and quality management systems that often require knowledge from several areas. Collaboration within the organization is common, providing quality and support in a resource-efficient manner to their clients.

Engaging regulatory professionals like those at Key2Compliance early in the process can significantly reduce costs and streamline product development. With correct expertise and insights into compliance and regulatory requirements, companies are able to focus on essential features and avoid unnecessary complexities. As Nadia points out, “Talking to someone with regulatory insight could really save companies a lot of money,” especially during the initial stages of product design. This early expert involvement ensures that development efforts align with regulatory standards, facilitating a smoother and more cost-effective path to market.

Early Involvement and Proactive Compliance with New Regulations
Mia Trustrup Larsen, addressing the challenges of complying with the new MDR regulations, states, “One of the biggest challenges that a lot of our customers have is that they previously were not required to prepare the technical file of their device under the MDD, and now they have to prepare it under the MDR, so they need to do everything backwards.” She emphasizes the necessity of early involvement in the process, saying, “We like to be involved from the beginning.” Mia’s expertise underscores the importance of anticipating regulatory shifts and advises startups to be proactive. “They should start with the documentation before they produce the product,” she says.

Cecilie Bengtsen further elaborates on the intersection of product understanding and regulatory compliance. “You need to understand the requirements of the devices, and then combine or apply these with the appropriate regulations,” she explains. It’s important to have a comprehensive approach where product specifics are intricately linked with the regulatory framework.

Navigating New Challenges with Key2Compliance’s Danish Team
The Danish team at Key2Compliance is well-equipped to assist both startups and established companies in overcoming the challenges posed by current regulations. From correctly classifying medical devices to preparing technical documentation, Key2Compliance’s consultants provide the necessary expertise.

The new MDR and IVDR regulations present an opportunity for startups in the medical device sector to elevate their standards in safety and performance. While these regulations introduce more detailed requirements for documentation, clinical evidence, and potential product reclassification, they don’t have to be seen as barriers. Startups can leverage expert regulatory support services to navigate these requirements efficiently. This approach allows the startups to focus on their core strengths – innovation and product development – while ensuring compliance and enhancing the quality of their medical devices. In essence, these regulations can act as a catalyst for growth and excellence, rather than an obstacle, in the ever-evolving medical device industry.

Personalized Expert Guidance for Your Medical Device Regulatory Needs
At Key2Compliance, we specialize in helping companies navigate the complexities of the MDR and IVDR regulations with a suite of tailored services. Our entire Nordic team of experts are dedicated to provide regulatory strategies to meet the unique needs of your company in alignment with the requirements of current regulations.

Having supported over 1000 companies on their road to CE-mark, we partner with you in every step of the process – from the initial concept to the market launch of your product. We provide expert guidance to ensure compliance, significantly reducing the risk of delays or rejections that can be costly. Understanding the criticality of risk management and compliance planning, we assist in identifying potential risks and developing comprehensive compliance plans.

Moreover, Key2Compliance is committed to empowering manufacturers with knowledge. We offer specialized training and educational resources, ensuring that your in-house teams are well-equipped with the latest regulatory knowledge and best practices. As always, when you work with Key2Compliance, you will have access to the entire company, which include over 70 experts, when you collaborate with any of us. This completely sets us apart from traditional staffing Companies and Companies focused only on one or two competence areas.

As the regulatory landscape continues to evolve, our ongoing support and updates will help you stay ahead, ensuring long-term compliance. With Key2Compliance by your side, you can focus on innovation and product development, confident in the knowledge that your regulatory needs are expertly managed.

Key2Compliance AB
Skeppsbron 44
131 28 Stockholm
Stockholms stad


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