Camneteq helps medical device and life science companies navigate regulatory complexity, strengthen quality systems and achieve sustainable market access.
Build and maintain audit-ready quality systems aligned with ISO 13485, MDR, IVDR, FDA and MDSAP requirements.
Internal audits, supplier audits and inspection readiness support aligned with ISO 13485, MDR and MDSAP.
Role-based training programs tailored to ISO 13485, MDR, FDA and MDSAP requirements, helping teams build competence and audit readiness.
Camneteq combines regulatory expertise, quality management and practical industry experience to help MedTech companies achieve compliance while supporting business growth.
Deep experience within medical devices, quality management systems and global regulatory frameworks including MDR, IVDR, FDA and MDSAP.
We focus on solutions that work in practice — helping organisations build sustainable processes rather than simply meeting minimum requirements.
From technical documentation to internal audits, we help companies stay prepared for inspections, certifications and market expansion.
Turning regulatory requirements into a foundation for growth and commercial success.
Let us introduce our founder
Tomas is a senior consultant in the life sciences sector, specializing in medical devices. He has worked in the life sciences industry since the mid-1980s.
In 1994, Tomas founded a consultancy focused on Quality Assurance (QA) and Regulatory Affairs (RA) within the medical device sector. The company grew organically over three decades and was acquired by a larger international group in 2024. At the time of the acquisition, the company employed approximately 75 people and operated offices in Stockholm, Gothenburg, Lund, and Copenhagen.
Tomas is passionate about solving complex QA and RA challenges by finding pragmatic solutions that meet regulatory requirements while maintaining a strong focus on patient safety.
https://camneteq.se/wp-content/uploads/2026/06/E4C16D44-93CD-4CB9-A75E-1A1F4E16EFF7.png
1024
1536
media2uadmin
https://camneteq.se/wp-content/uploads/2026/06/logotype.png
media2uadmin2026-06-21 16:26:502026-06-21 16:26:50We’re at “Almedalsveckan” in Visby
https://camneteq.se/wp-content/uploads/2016/02/medical-team-1.jpg
720
1500
media2uadmin
https://camneteq.se/wp-content/uploads/2026/06/logotype.png
media2uadmin2026-04-30 18:59:532026-06-12 15:15:56MDCG
https://camneteq.se/wp-content/uploads/2026/06/medicine-uniform-healthcare-medical-workers-day-nurse-day-scaled.jpg
1707
2560
media2uadmin
https://camneteq.se/wp-content/uploads/2026/06/logotype.png
media2uadmin2026-02-28 18:49:482026-06-15 16:07:17MDSAP Audit Approachof experience
Audits Supported
Quality Systems Implemented
Countries & Markets Supported
Beyond Compliance
We help investors, private equity firms and acquirers uncover regulatory, quality and operational risks before they impact valuation. By combining deep MedTech expertise with a structured due diligence approach, we deliver the insights needed to make informed investment decisions with confidence.
Read more about
Evaluate regulatory, quality and compliance risks before acquisitions, investments and strategic transactions.
Contact us
Whether you need support with quality systems, audits, training or due diligence, we’re here to help.