Medical Technology & In Vitro Diagnostics
We develop safe, sustainable and innovative MedTech products. With cutting-edge technical expertise and deep regulatory knowledge, we bring your ideas to life – safely and efficiently.
We support our customers in developing sustainable medical devices that really make a difference.
Victoria Hultdin, Consultant Manager Life Science
MedTech with us
We are an ISO 13485-certified* development and design house with extensive experience in product development for medical devices (MD) and in-vitro diagnostics (IVD). Our projects range from software and electronics to mechanics, industrial design and UX, test and validation, as well as quality assurance and regulatory compliance. Whether you need a complete development team or reinforcement in a specific phase, we have the right skills to support you throughout the entire product lifecycle – from early concept to market surveillance.
We have our own mechanical and electronics lab, and the ability to perform pre-compliance tests in our EMC chamber, as well as test equipment for climate and electrical safety tests.
Why customers choose us
Developing medical devices requires high levels of safety, performance and regulatory compliance. With our extensive experience and cross-functional expertise, we help you manage these demands without losing momentum or innovation.
We know how important it is to identify the right technical path early on, define requirements and build quality into every step. Our work is structured, yet flexible – tailored to your product, market and business. With our experience and knowledge, you reach the market faster, minimize risks and get sustainable, high-quality products that stand the test of time.
What can we help you with?
We offer both comprehensive and targeted interventions in medical device development, tailored to your needs. Our areas of expertise range from project management and system architecture to software development, electronics and mechanics. We also have strong expertise in UX, usability and industrial design, as well as in quality assurance, regulatory strategy and compliance according to MDR, IVDR and FDA's CFR (Code of Federal Regulations).
In addition to this, we work with verification, validation and testing, EMC and electrical safety, as well as advanced areas such as artificial intelligence, machine learning, data integrity and cybersecurity. We also offer support for lifecycle management and product care.
With this breadth, we cover the entire product lifecycle – from concept development and requirements to technical documentation, CE marking and transition to production, followed by market access and aftermarket management.
EXPLORE
Curious about our projects?
Our team
Our teams are comprised of experts with diverse backgrounds in technology, design, usability, quality assurance and regulatory compliance (QA/RA). We work seamlessly across disciplines to create solutions that meet both user needs and regulations. With access to complete development environments and in-house labs for pre-compliance testing, we offer a safe and efficient path from idea to approved product.
*) We are certified according to ISO 13485 in Stockholm, Uppsala and Copenhagen.
Organizations & partners
Swedish Medtech, SmiLe, UIC, Medeon Science Park, Medea and the Society of Pharmacists.
It's not just about meeting requirements – it's about building trust.
Micael Johansson, Project Manager, MedTech Production Development