The right Medical Device consultant can speed up the time to market for your organization. However, choosing a consulting firm that fits your company’s needs can be a challenging process. Simply because too many aspects of product development must be taken into consideration – Quality Assurance, Regulatory Affairs, Device development, Training Management, SOPs, selection of an eQMS solution, and others.

Fortunately, we have done the research and created a list of the best consulting firms in Denmark that could assist your organization.

17 Medical Device Consultants in Denmark

Genau & More

Genau & More provides a wide range of compliance services to Life Science companies to ensure that patient safety is never compromised and that the organization is always inspection-ready. Some of the onsite and offsite services that Genau & More offers are project management, validation, training, quality & compliance.

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SAXOCON is a consulting company that helps Medical Device and other product manufacturers test, document, and certify that their products are in compliance with regulations and guidelines both in the EU and worldwide. The firm also provides specific Medical Devices services for drug products, breathing gas pathways, in vitro diagnostic, stents, and implants.

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RAQA advises and supports medical device companies and local councils/hospitals in Regulatory Affairs and Quality Assurance compliance from their office in Ringsted, Denmark. Their goal is to provide clients with the tools to understand and navigate the applicable regulations, guiding and supporting their compliance processes as needed.

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IWA Consulting

IWA Consulting is a group of regulatory affairs specialists providing expert services to a range of international private and public clients within industries like Medical Device, Biotech, and Pharma. The consulting firm has long-term experience within regulatory affairs, in-depth knowledge, and an understanding of the sense of urgency that applies to this business area.

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Pharmaceutical Engineering Consultants (PEC)

Pharmaceutical Engineering Consultants (PEC) is an innovative engineering consultancy that assists and manages projects within the Life Science industry. The firm has grown into one of the leading consultancy companies in Denmark within the field of production of Medical Devices and can contribute in most phases of a device project.

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Qmed Consulting

Qmed Consulting is a global full-service Contract Research Organization (CRO) based in Copenhagen, Denmark. The firm provides strategic consulting services in connection with Medical Device approval as well as best-in-class expertise in clinical affairs, regulatory affairs, quality management, and commercial healthcare.

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SPT VILECON is offering customer-oriented consultancy, design, development, and construction services to the Medical Device and Pharmaceutical industries. The firm specializes in between design, development, and construction of Medical Devices on one hand, and injection molding on the other.


Emendo Consulting Group

Emendo Consulting Group’s background-origin is within the Pharmaceutical and Food industry, but nowadays the company works across all industries, including Medical Device. The firm provides unique process expertise to all phases of a product lifecycle, from early development, the establishment of new equipment/production facilities to process optimization.

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Medicologic has a team of dedicated freelance consultants and specialists that help companies develop solutions that meet the expectations, requirements, and challenges in the Medtech and Pharma markets. The consulting firm provides services like In-Housing, MDR- & IVDR, Service Agreements, QMS, and others.

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AlfaNordic is a consulting company with more than 90 employees working in the Life Science industry. The firm specializes in Pharmaceutical production, Project management, Management consulting, Validation, Production support, IT/AUT, QA/QC, Medical device, Regulatory Affairs (RA), and Pharmacovigilance (PV).

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Technolution is a consulting company that helps Medical Device companies within areas like Mechanical engineering, Usability Engineering (HFE), Design & User Experience (UX), Test & Verification, Design Control, Business Development, and Quality Management. The firm also retains a special focus on Pharma companies, as well as MedTech start-ups.

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Sigma Quality & Compliance

Sigma Quality & Compliance offers consultancy services within various processes such as production, product development, research, testing, and purchasing. The company has a long and solid experience in both Life Science and other quality-controlled businesses. 

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Borgensgaard Consulting

Borgensgaard Consulting provides a variety of consulting services to companies in the Life Science industry like Medical Device, Pharmaceutical, and Biotech but is also very relevant for other industries. The firm specializes primarily in Quality Leadership, Quality Management, Regulatory Compliance, and Human Behavior.

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Aquilo Consulting

Aquilo Consulting is an international management consulting firm specialized in developing and implementing growth strategies for private healthcare companies and public healthcare organizations. The company helps Medical Device, Pharmaceutical companies, and other healthcare providers grow the quality, efficiency, and profitability of their businesses.

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Pharmakia is a Private Limited Company managed by an owner who is also a consultant. The owner of the consulting firm, Stephane Labrosse, can help you in the areas of Project Management, Quality Assurance, Regulatory Affairs, Validation, and Technical Expertise in Medical Device development.

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MEDQURE Consultancy

MEDQURE provides Regulatory Affairs courses and consultancy to Medical Device manufacturers in Project management, Quality Assurance, Product development, and other field areas. The firm offers consulting services to medium and large Medtech, Diagnostic, Rehab, Dental, and Telemedicine companies.

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MedicQA is a Medical Device consulting company with a focus on quality management. The company aims to support companies, of all sizes, in establishing the necessary regulatory and quality framework around the activities of product development, manufacturing, and marketing. 

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

The aforementioned consultants we find one of the better ones in Denmark. In case you have other suggestions or would like to see your consultancy firm among the best Medical Device consulting firms in Denmark, please contact us.

Be aware that each inquiry is processed manually to ensure that only relevant and highly reputable consultancies get featured on our list.

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