Medical Device consulting companies in Sweden include a variety of consultancies with different specializations – Quality Assurance, Medical Device Classification, Regulatory Submissions, Training Management, Device development, as well as the selection of the right QMS software solution. The right consulting firm for your Medical Device company is likely to differ based on factors, like your budget, project goals, company size, and geographic location.

The list below includes the best consulting firms in Sweden that could assist your organization and help to bring your product to market quicker.

15 Medical Device Consultants in Sweden


KEY2COMPLIANCE specializes in Regulatory Affairs, Quality Assurance, Biological Evaluations and Toxicology, and Clinical Development services specifically for Medical Device Companies for companies involved in the development, manufacturing and beyond. The firm also offers programs for Training and Education for both Pharmaceuticals and Medical device products throughout the full product life cycle.

Key2compliance Logo


Clarvin is a consulting firm focused exclusively on Regulatory Affairs and Quality Assurance for Medical Devices. The firm has extensive experience with EU and US medical device regulations and aims to create value for its clients by providing customized strategic input to the company´s regulatory compliance scheme.

Clarvin Logo

Scandinavian CRO

Scandinavian CRO is a full-service Contract Research Organisation offering both consultancy and specific, stand-alone services. The company performs complete studies or parts of projects within the field of clinical trials for both Pharmaceuticals and Medical Device. When hiring a consultant from Scandinavian CRO, you can choose between specialists, like project managers, clinical research associates, administrators, and research nurses.

Scandinavian CRO Logo

Scandinavian Regulatory Services (SRS)

Scandinavian Regulatory Services (SRS) is a consultancy company offering regulatory expertise and services to the Medical Device, Pharmaceutical, and associated industries. SRS has a team of Regulatory Affairs and Quality Systems specialists with extensive experience from all different aspects of Regulatory Affairs and Quality covering a wide range of products.

Scandinavian Regulatory Services AB (SRS) Logo

SDS MedteQ

SDS MedteQ provides consultancy services within the Medical Device field. The company specializes primarily within areas like Regulatory affairs, Registration/Submission, Quality Assurance, QMS Development, Technical Documentation, Gap Analyses, Biocompatibility, Statistics, and Project Management.

SDS MedteQ Logo


PlantVision helps Life Science companies transform manufacturing, laboratory, and quality operations using a customer-centric, integrated approach. For this, the firm provides consulting and professional services together with the market’s most complete range of industry-leading solutions in this area of Life Science.

PlantVision Logo

QARA Consulting 

QARA Consulting is a consultancy company with a team of senior, expert consultants supporting clients in the Medical Device industry. The firm offers a complete range of multidisciplinary quality and regulatory services from initial device classification, technical file writing, and clinical evaluations, to post-market surveillance.

QARA Consulting Logo

RegSmart Life Science

RegSmart Life Science is a regulatory consultancy firm that helps Medical Device and Pharmaceutical companies navigate in a complex and evolving regulatory landscape. With long regulatory and scientific experience from senior roles at the regulatory agency and from small and big Life Science companies, the firm can build your regulatory strategy in line with current thinking.

RegSmart Life Science Logo


QAdvis is a longstanding provider of Quality and System Management, Risk Management, Compliance, Training, Interim Management, and Regulatory Affairs. Offering a thorough knowledge and understanding of the Medical Device industry, based on 30 years of professional experience, QAdvis has the tools to help take MedTech innovations to domestic and international markets.

QAdvis Logo

Scientific Solutions Scandinavia

Scientific Solutions Scandinavia specializes in management and specialist roles mainly within Regulatory and Medical Affairs, QA, PV, and Compliance. The firm provides clients with customized solutions of scientific professionals – temporary, permanent, or somewhere in between and is passionate about matching company needs with individual experience, personality, and commitment.

Scientific Solutions Scandinavia Logo


MedQtech is a consulting company with experienced professionals with high competence who support customers in the Medical Device industry within areas like Quality and Regulatory compliance. The firm can support you in writing specific processes or implementing a full Quality Management System. It also provides customized training within the regulatory and quality field in the Medical Device Industry.

MedQtech Logo

Pharm Assist

Pharm Assist is a consultant and service company offering regulatory solutions for Medical Device and Pharmaceutical companies. The company has a team with a strong scientific and regulatory background provides tailor-made services in Regulatory Affairs, Pharmacovigilance, Medical Writing, and GDP to national and international companies.

Pharm Assist Logo

J.F.B Consulting

J.F.B Consulting has a network of consultants that brings over 40 years of experience with the goal of providing Medical Device, Pharmaceutical, and Biotechnology companies with a high level of service and dedication. The firm specializes in Strategy, Sales & Marketing, Health Economy, Market Access & Pricing, Product Planning, Supply Chain Guidance.

J.F.B Consulting Logo

Fjord Consulting

Fjord Consulting performs consulting services in the areas of Quality Management, Product Development, Project Management, Training, and Product Registrations. The main branch is within the Medical Device and the Life Science industry. The firm has consultants with more than 12 years of experience in leading positions within this area.

Fjord Consulting Logo


Devicia provides full-service solutions and consultancy services within the Medical Device industry. The firm specializes in Quality, Regulatory, and Clinical Affairs. Therefore, it offers full-service solutions within Medical Writing, Clinical Investigation consultancy services, Regulatory Affairs, and Training modules within regulatory and clinical processes.

Devicia Logo

Recommended Reading: How To Choose the Right Consultant for Your Medical Device

The consulting firm list features better service providers in Sweden. Feel free to suggest a company that would be worthy to be featured on the list. However, if you would like to see your consultancy company be on the list among the best Medical Device consulting firms in Sweden please contact us.

Be aware that new inquiries are processed one by one to ensure that only highly relevant consultancies get featured on the list.

Here are the lists of Medical Device consultancies that provide their services primarily in other countries, such as: