Medical device consultancy in Scandinavia for sale

Company for sale

Size: Small
Revenue: <5M Euro
Location of the company: Scandinavia
CFIE PHS168

Overview of Medical device consultancy in Scandinavia for sale

A well-established medical device consultancy in Scandinavia is available for acquisition. Specializing in regulatory compliance, quality management, and market access for medical devices and in vitro diagnostic (IVD) devices, the company has built a strong reputation as a trusted partner in the industry. With extensive expertise in navigating complex regulatory landscapes, the company provides strategic guidance and hands-on support to ensure compliance and successful market entry.

Profile of Medical device consultancy in Scandinavia for sale

Founded over a decade ago, the company has developed a solution-oriented approach to supporting medical device manufacturers. It works with both startups and established organizations, helping them streamline their development processes, mitigate risks, and accelerate their time to market. The consultancy’s team, combined with an extensive international network, enables a high level of expertise across various medical device categories and regulatory frameworks. The company is certified under ISO 13485:2016, ensuring adherence to the highest quality management standards.

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Activity and Services of Medical device consultancy in Scandinavia for sale

The company offers comprehensive regulatory and compliance support for medical devices and in vitro diagnostic (IVD) products. Its expertise spans regulatory strategy development, ensuring compliance with international regulations such as EU MDR/IVDR and FDA requirements. It assists clients in implementing and maintaining ISO 13485-compliant Quality Management Systems (QMS) to streamline regulatory approvals. Additionally, the company provides market access and certification support, guiding manufacturers through CE marking, FDA approval, and other regulatory processes. The consultancy also specializes in preparing and reviewing technical documentation, ensuring regulatory readiness for product submissions. By working closely with clients, the company integrates seamlessly into their operations, offering tailored solutions that optimize regulatory pathways and accelerate market entry.

Highlights of Medical device consultancy in Scandinavia for sale

Established Industry Presence – Over a decade of experience providing consultancy services in the medical device and IVD sectors.
Comprehensive Regulatory Expertise – Specializes in EU MDR, IVDR, FDA regulations, and global market access strategies.
End-to-End Compliance Support – Covers all phases of a medical device’s lifecycle, from concept to post-market surveillance.
Strong International Network – Collaborates with industry partners and regulatory bodies worldwide.

More information on this medical device consultancy in Scandinavia for sale

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