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 Develop your product
Assure compliance to MDR - FDA
Clinical Investigation - Roles & Responsibilities
BAAT Medical - From medical idea to market success
BAAT Medical passed the ISO 13485 recertification audit

From idea to market success

Development

Medical Device Development

From idea-to-market medical device to deliver your device to end-users worldwide. This is what we do on a daily basis. With our Development you get all services integrated into a proven system so that you get the confidence to launch and deliver your device within your milestones:

  • Design
  • Development
  • Manufacturing
  • Certification
  • Distribution
Contact us today

Production

Medical Device Contract Manufacturing

How to turn your idea into a tangible device? Which suppliers to select that best fit your market? We know how to select and qualify medical device suppliers so let’s choose the ones that best fit your device and market. We setup and manage supply chains worldwide and we can do this for you too so you can focus on what drives you most; if that is technology development, sales and marketing or something else. Let’s manufacturing your device and relief you from:

  • Legal & Contract Manufacturing
  • Design for Manufacturing
  • Supply Chain Setup
  • Distribution
Contact us today

Testing

Medical Device Testing

Demonstrating safety and efficacy is critical to your medical device’s success both before and after market approval. We cover all medical device testing areas such as, but not limited to:

  • Clinical
  • Biologic Safety
  • Usability
  • Mechanical
Contact us today

Consulting

Medical Device Consulting

Are you looking for an external expert or do you prefer to place an expert consultant in your company? We are here for you. Our experts cover all relevant medical device topics such as, but not limited to:

  • Regulatory & Quality
  • Clinical
  • Biologic safety
  • Manufacturing validation
Contact us today

Training

Medical Device Training

How to get ISO 13485 complicance? Which regulatory route to take? Which coating to select? And all other questions that you might have related to your medical device. From beginner courses to refresher trainings and customized courses. Your education is our top priority in our trainings solution. Our trainings cover all topics related to medical devices as we provide:

  • Public courses
  • In-house training
  • On-demand training
  • Seminars
Contact us today

Medical Device Development

From idea-to-market medical device to deliver your device to end-users worldwide. This is what we do on a daily basis. With our Development you get all services integrated into a proven system so that you get the confidence to launch and deliver your device within your milestones:

  • Design
  • Development
  • Manufacturing
  • Certification
  • Distribution
Contact us today

Medical Device Contract Manufacturing

How to turn your idea into a tangible device? Which suppliers to select that best fit your market? We know how to select and qualify medical device suppliers so let’s choose the ones that best fit your device and market. We setup and manage supply chains worldwide and we can do this for you too so you can focus on what drives you most; if that is technology development, sales and marketing or something else. Let’s manufacturing your device and relief you from:

  • Legal & Contract Manufacturing
  • Design for Manufacturing
  • Supply Chain Setup
  • Distribution
Contact us today

Medical Device Testing

Demonstrating safety and efficacy is critical to your medical device’s success both before and after market approval. We cover all medical device testing areas such as, but not limited to:

  • Clinical
  • Biologic Safety
  • Usability
  • Mechanical
Contact us today

Medical Device Consulting

Are you looking for an external expert or do you prefer to place an expert consultant in your company? We are here for you. Our experts cover all relevant medical device topics such as, but not limited to:

  • Regulatory & Quality
  • Clinical
  • Biologic safety
  • Manufacturing validation
Contact us today

Medical Device Training

How to get ISO 13485 complicance? Which regulatory route to take? Which coating to select? And all other questions that you might have related to your medical device. From beginner courses to refresher trainings and customized courses. Your education is our top priority in our trainings solution. Our trainings cover all topics related to medical devices as we provide:

  • Public courses
  • In-house training
  • On-demand training
  • Seminars
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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Dymphy van der Wilk BAAT Medical

Dymphy van der Wilk

Business Development

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