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Hoff & Lowendahl AB is a quality and regulatory affairs consulting firm based in Knivsta, Sweden. Its services focus on market access and compliance for medical devices, IVDs, laboratories, and manufacturing-related products. According to the website, it can act as an EU Authorized Representative (AR) for non-EU manufacturers and take on the PRRC role in countries including Denmark, Germany, the Netherlands, and Sweden.
Its services cover regulatory affairs, market access strategy, MDR/IVDR readiness, FDA 510(k), De Novo, pre-submissions, product classification, gap analysis, labeling and promotional compliance, and communication with regulatory authorities. On the quality system side, the website mentions ISO 13485, ISO 9001, ISO 14001, FDA QSR, internal audits, mock audits, and inspection support. It also offers trade compliance, export controls, ECCN classification, export licensing, and various training courses.
The website does not disclose specific pricing, only stating that users can contact the company for pricing on services such as AR support. It also mentions that it typically offers three types of service packages: Bare minimum, Good enough, and Best in class. The company emphasizes that most work can be completed remotely to save clients time and costs, making it well suited to cross-border consulting projects.
Its strengths lie in a relatively comprehensive regulatory and quality system service chain, coverage of both EU and U.S. market access, and an emphasis on extensive experience with FDA, notified body, and competent authority inspections. It also appears friendly to startups and small manufacturers. The downside is that it is not a typical SaaS or enterprise software product: there is no visible online platform, API, permissions management, integrations, dashboard, or self-service workflow. Pricing, project timelines, SLAs, and customer case studies are also not transparent.
It is best suited for medical device and IVD companies, especially teams that need EU AR, PRRC, CE marking, MDR/IVDR, FDA submissions, or quality system development. It is not suitable as a general enterprise software procurement option.
The captured text does not provide information on availability from mainland China, so this is considered unknown.
⚠ This review is compiled from public sources and does not constitute a purchase recommendation. Verify all facts on the vendor's official site. Verify on lowendahl.eu official site.
lowendahl.eu is an Sweden SaaS provider. TG4G tracks its product information, an overall rating of 6.0/10, and a China-accessibility score of Workable. Click "Visit Official Site" to reach lowendahl.eu directly.