AI MEETS COMPLIANCE

Smart solutions for MedTech startups and SMEs

HP MED Consulting

ABOUT

Founded in 2023 as the innovation division of HP Technology Group, HP Med Consulting combines deep domain expertise with a focus on emerging technologies in the medical device, life science and healthcare industries.
It offers the best of both worlds: the dynamism and agility of a young company with the profound expertise and experience of an established enterprise.

Vision & Mission

Our vision is to revolutionize the process of medical device approval by merging traditional methods with state-of-the-art technology.
We empower medical device manufacturers with a seamless, fast and efficient approval process, ultimately enhancing patient safety and product quality.

REGULATORY

We guide you safely through the complex regulatory requirements for medical devices globally. Collaboratively, we develop customized approval strategies, ensuring a smooth market entry for your medical products.

QUALITY

We specialize in developing and maintaining effective quality management systems for medical devices, in accordance with industry standards such as ISO 13485, 21 CFR 820 and AQAP-2110. Our objective is to strike the perfect balance between rigorous quality standards and streamlined process optimization.

We use artificial intelligence to optimize the approval process for medical devices and ensure the safety and efficacy of your medical products consistently.

TECHNICAL

We take care of creating the necessary technical documentation for your medical devices in accordance with strict regulatory requirements (Regulation (EU) 2017/745, 21 CFR 800 ff.).
Our commitment: controllable risks and precise documentation for an efficient approval process.

CLINICAL

Our proficiency in Clinical Affairs includes precise clinical evaluations for medical devices, along with comprehensive Post-Market Surveillance management.
Our overarching objective is to guarantee the highest quality for your products throughout their entire lifecycle.

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