Medical device engineering

Do you have a great idea for a medical device and need a partner to realize it and make it ready for market approval? Is your development portfolio bigger than your R&D department’s capacity?

BAAT is your partner in expert medical device design engineering. BAAT has the experience and know-how to transform your dream, idea, technology or problem into a product with manufacturing route, CE/FDA application and operations.

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Medical Device Engineering – expertise at your Fingertips

Medical device engineering is applying engineering principles for healthcare purposes. It is not just calculations, drawings and tolerances; it is about creating a meaningful impact on the lives of patients. During the journey from idea to product there are important questions to answer, many of them not of technical nature:

  • What concept works for all users (patient, OR assistant, surgeon, etc.)?
  • How can all users safely and effectively use the medical device? (human factors engineering medical devices)
  • How can the design, production process and packaging be fully specified?
  • Who can work together to make it?

Medical device engineering and path to success graph

More Engineering challenges and asking the right questions

Asking the right questions is the first step to a successful project. Having impact on the end user means impact in the market. Some examples:

  • How can we prove safety and performance for the patient and other users (human factors engineering medical devices)?
  • What strategy and information will lead to market approval?
  • How can we ensure the medical device is fully monitored and traceable from raw material to clinical use?
  • How is the clinical performance of the products tracked and continued access to the market ensured? This is another example of human factors engineering medical devices

One of the steps many customers do is answering above questions using an Innovation Scan. We call it ‘Innoscan’. Get in contact with Baat to see what can lead to a commercially viable product development and real impact in the medical device business.

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Assure compliance to MDR - FDA
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From idea to market success

Define your business

Build a compelling business case to attract investor funding, backed by our 25 years of MedTech expertise and our global industry network.

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Develop your product

Accelerate time-to-market with our integrated development process and engineering expertise tailored for MedTech.

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Manage your supply chain

From prototype to scale up, we create a flexible, cost-effective supply chain with access to our network of trusted, high-quality suppliers.

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Assure compliance to MDR / FDA

Navigate FDA and CE requirements to secure certification through our regulatory expertise and ISO-standard compliance.

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Monitor patient safety

Prove your device’s value with clinical data that highlights patient benefits, resonates with investors, and aligns with market needs.

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Bear legal responsibility

Minimize legal risks with our comprehensive support in warehousing, distribution, post-market surveillance and change control.

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Build a compelling business case to attract investor funding, backed by our 25 years of MedTech expertise and our global industry network.

Contact us today

Accelerate time-to-market with our integrated development process and engineering expertise tailored for MedTech.

Contact us today

From prototype to scale up, we create a flexible, cost-effective supply chain with access to our network of trusted, high-quality suppliers.

Contact us today

Navigate FDA and CE requirements to secure certification through our regulatory expertise and ISO-standard compliance.

Contact us today

Prove your device’s value with clinical data that highlights patient benefits, resonates with investors, and aligns with market needs.

Contact us today

Minimize legal risks with our comprehensive support in warehousing, distribution, post-market surveillance and change control.

Contact us today

Medical Device Engineering Certification ISO 13485 batch

ISO 13485 Certification

Our ISO 13485 quality system (certificates) concerns topics directly related to product development (e.g. verification and validation, risk management, usability), but also addresses many high-level topics such as competence tracking and training, management of standards, control of documents.

When partnering with BAAT, you will not only benefit from the knowledge and experience of our 25+ people with various fields of expertise, our expertise with medical device engineering for both the EU and US markets with 30+ products developed (publication list), but also of our underlying quality system.

It’s all about the quality system to get regulatory approval

Even the best and most experienced medical device design engineers are only as good as the quality system they are working under. At least according to the authorities assessing market approval. That means a team of experts in medical product engineering is not enough; they must use a thorough quality management system to get regulatory approval for a medical device.

Overview image of Quality system medical engineering process

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Gert Nijenbanning BAAT Medical Products

Gert Nijenbanning

Business development

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