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 design engineer showing a medical hip implant

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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BAAT Medical - From medical idea to market success
BAAT Medical Develop your product
BAAT Medical Manage your supply chain
Assure compliance to MDR - FDA
BAAT Medical monitor patient safety
BAAT Medical Bear legal responsibility

From idea to market success

Define your business

At BAAT Medical, we guide you in looking ahead to a prosperous future. Together, we will identify key stakeholders, assess external factors, and craft a compelling business case. Our 20+ years of experience in the medical device sector ensures that your journey from concept to market is both visionary and grounded, setting clear milestones and budgets. Partner with us to define and refine your business strategy, leveraging our deep industry knowledge for your success.

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Develop your product

At BAAT Medical, our journey to market readiness is defined by a controlled, transparent process. We integrate design, engineering, and risk management with rigorous verification and validation. Selecting the finest in the supply chain and ensuring comprehensive user information, we uphold the highest standards of clinical evaluation. Our meticulous technical documentation and a robust Device Master Record (DMR) affirm our compliance with MDR and FDA regulations, setting the stage for your device’s success.

Contact us today

Manage your supply chain

At Baat Medical, seamless supply chain management is crucial after your product hits the market. We handle order processing, timely deliveries, and engineering change orders with precision. Our operational services are designed to sustain and enhance your product’s market presence. Trust in our comprehensive approach for continuous clinical follow-up and supply chain excellence.

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Assure compliance to MDR / FDA

Use the BAAT Quality Management System to accelerate your time to market during development and setting up your supply chain and after launch for your life cycle management. Our Quality Management System is always updated for MDR and FDA regulations.

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Monitor patient safety

Clinical evidence is more important than ever. We can create your Clinical Evaluation Report and assist setting up clinical trials in US and EU. And after market introduction we keep your technical file up to date with PMS and PSUR.

Contact us today

Bear legal responsibility

How to organize the formal responsibility of being legal manufacturer? And how to keep your device on the market and manage the life cycle of your device? We can be your legal manufacturer while you hold your identity and IP.

Contact us today

At BAAT Medical, we guide you in looking ahead to a prosperous future. Together, we will identify key stakeholders, assess external factors, and craft a compelling business case. Our 20+ years of experience in the medical device sector ensures that your journey from concept to market is both visionary and grounded, setting clear milestones and budgets. Partner with us to define and refine your business strategy, leveraging our deep industry knowledge for your success.

Contact us today

At BAAT Medical, our journey to market readiness is defined by a controlled, transparent process. We integrate design, engineering, and risk management with rigorous verification and validation. Selecting the finest in the supply chain and ensuring comprehensive user information, we uphold the highest standards of clinical evaluation. Our meticulous technical documentation and a robust Device Master Record (DMR) affirm our compliance with MDR and FDA regulations, setting the stage for your device’s success.

Contact us today

At Baat Medical, seamless supply chain management is crucial after your product hits the market. We handle order processing, timely deliveries, and engineering change orders with precision. Our operational services are designed to sustain and enhance your product’s market presence. Trust in our comprehensive approach for continuous clinical follow-up and supply chain excellence.

Contact us today

Use the BAAT Quality Management System to accelerate your time to market during development and setting up your supply chain and after launch for your life cycle management. Our Quality Management System is always updated for MDR and FDA regulations.

Contact us today

Clinical evidence is more important than ever. We can create your Clinical Evaluation Report and assist setting up clinical trials in US and EU. And after market introduction we keep your technical file up to date with PMS and PSUR.

Contact us today

How to organize the formal responsibility of being legal manufacturer? And how to keep your device on the market and manage the life cycle of your device? We can be your legal manufacturer while you hold your identity and IP.

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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Contact our expert

Gary Antonius from Baat Medical

Gary Antonius

New Business Development Global

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