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BAAT Medical

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BAAT Medical’s unique selling point is their end-to-end expertise in medical device development, encompassing engineering, clinical evaluation, certification, and optimizing user experience, ensuring successful commercialization and a meaningful impact on healthcare.

BAAT Medical specializes in medical device development and offers services related to medical device design consultancy, regulatory consulting, and quality testing. They work with medical startups and healthcare entrepreneurs to bring their products to market, which typically involves engineering and clinical evaluation, ensuring that the devices meet the necessary certification and quality standards. Additionally, the focus on “customer validation & user experience” is crucial in the medical device industry, as these devices need to be user-friendly and meet the needs of healthcare professionals and patients. Therefore, these areas align closely with the expertise and services offered by BAAT Medical.

How can Baat Medical help you?
Regulatory support:

  • For researchers: Assisting in meeting clinical study requirements for data utilization in medical device certification.
  • For start-ups: Providing guidance on the essentials for bringing a medical concept to market and maintaining compliance.
  • Notified Body: Offering start-ups access to BAAT’s notified body services, eliminating the need for them to find one separately (BAAT is associated with Dekra & MedCert).

Company certification & FDA:

  • Utilizing BAAT’s CE MDR and FDA-certified Quality Management System (QMS), reducing the need for startups to establish their own.

Product development

  • Develop your product and manufacturing process and provide all documentation needed to get market approval. The BAAT team can provide you with the right input to decide on next steps in the process.

Manufacturing:

  • Ensuring that medical products can be manufactured effectively to meet quality standards.

Validations:

  • Conducting various validations, including cleanliness, sterility, strength, clinical performance, proper usage, manufacturing, and post-transport performance.

Sustainability:

  • Maintaining a product’s presence in the market over time.

Start-up support by BAAT:

  • BAAT Medical offers a short trajectory to define an idea and/or articulate the problem: InnoScan. The aim of this trajectory is to make you think about all facets of your start-up and gain external feedback to write a convincing business case.

BAAT Medical

Hazemeijer Hengelo – Building A04 | F. Hazemeijerstraat 800
7555 RJ
Hengelo

Contact

Dymphy van der Wilk
+31613620802

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