Accelerate your Medical Device development
The Medace model enables sustainable Medical Device development and manufacturing resulting in greater efficiency.
- Our approach
- ISO 13485 QMS template
- ISO certified facilities
- Flexible training
- Key benefits
- Download brochure
Our approach
Medace offers emerging companies and academic groups the required on demand infrastructure and support to promote and de-risk their in-house development while reducing capital expenses. This falls within the scope of our ISO 13485 certification.
Designed to save time and lower costs, the Medace pick-and-choose model enables you to efficiently advance your product from pre-clinical development through clinical manufacturing. Whether you are an ambitious academic group or emerging company, our approach to Medical Device development and manufacturing reduces costs and risk, while improving overall product quality.
From the Medace pick-and-choose menu (shown below) you can select the required facilities and support you need to accelerate and de-risk your product development. Our unique model offers you on demand rental of ISO class 7 cleanrooms with supporting infrastructure, R&D labs and mechanical testing equipment as well as a dedicated team of experts from Medace to support your dynamic requirements.
These integral services help emerging companies, academics and research hospitals bring their innovation to the patients faster.
- Rent facilities and support on demand
- Remain agile throughout development
- Lower outsourcing costs and capital expenses
- Built in-house manufacturing expertise
- Attain your own and product-specific Quality Management System based on the template of our ISO 13485 Certified QMS
Contact us to discuss how we can support your development.
ISO 13485 QMS template
Medace has a unique service model in which we leverage our EN ISO 13485:2016 management system to accelerate the product development of our clients.
The scope of our certification is as followed; Service provider by maintaining a QMS template, environment and infrastructure, equipment, monitoring and measuring services, while offering technical support and training, for medical devices and biomaterials. Certificate is available upon request.
Our Quality Assurance experts help you set-up and implement your own Quality Management System (QMS). Our team starts from Medace’s overarching QMS as backbone when developing your own QMS, thereby reducing crucial time and resources for fundamental elements of quality assurance and certification. Our experts can support during the full lifecycle of your product from Proof of Concept date generation up to and including product release for clinical trials.
- Quality Assurance experts to support your development
- Ready-to-use templates, work instructions and procedures in place
- Develop your own and product-specific QMS with our certified template
More information about Quality Management.
ISO certified facilities
Medace offers on demand ISO class 7 cleanroom rental, laboratory rental and specialized equipment for emerging companies and academic groups at our 2100 square meter facility. The ISO cleanrooms are equipped, serviced and specifically designed to allow small scale and cost-effective manufacturing of Medical Devices. At the same time we offer flexible rental agreements to match your dynamic requirements.
The fully-equipped mechanical, microscopy, chemical and tissue culture R&D labs provide a controlled environment for the development and optimization of your product while reducing capital expenses. Equipment, consumables and support is all available.
The Medace Medical Device capabilities consist of;
- 5 ISO class 7 cleanrooms w. QC-rooms
- Development laboratories & controlled warehousing
- Medical Device testing equipment
- Office and meeting space
Explore your new R&D and manufacturing facility online.
Flexible training
With Medace’s training courses you and your team can gain expertise on a wide range of quality, regulatory and experimental topics related to Medical Device development. As attracting experienced talent to your team can be challenging we provide comprehensive training courses to expand the skills of your own team. Moreover, we believe that this way of product development is more sustainable than outsourcing as you acquire the knowledge to repeat the process yourself. Topics range from Introduction into Medical Device Regulation (MDR) to Failure Mode and Effects Analysis (FMEA).
- Built your professional team
- Decrease the need for outsourcing key tasks
Explore some of our training possibilities.
Key benefits
In summary, Medace offers many benefits to emerging companies and academic developing Medical Devices. As these products are often complex to develop it’s important to maintain a maximum level of flexibility and keep capital expenses low to achieve long term success. That’s why Medace provides cost-effective, flexible and efficient solutions for companies developing these promising products to support their pathway to the patient.
- Accelerate timelines by making use of existing infrastructure
- Start from our ISO 13485 certified QMS to accelerate your certification
- Keep your IP in-house, no tech transfer required – your team remains in control
- Reduce capital expenses and operating costs, rent facilities and support on demand
- Your own product specific Quality Management System
- Gain in-house knowledge, expertise and built talent within your company
Let’s discuss how we can help de-risk and accelerate your product development.
Download Brochure
More information about our solutions for Medical Device development.
Our services and products
1. R&D labs and equipment
Medace offers fully-equipped flexible tissue culture lab space and dedicated labs for rent in our 2100 square meter facility. Starting from a single bench space up until fully dedicated labs. Flexible rental agreements and fully equipped and licensed for the development of cell-based products to reduce your capital expenses and timelines.
2. Classroom and hands-on training
With Medace’s training courses you gain expertise on a wide range of quality, regulatory and experimental topics related to Medical Device development. Ranging from Introduction into MDR to FMEA.
3. Specialized equipment
At Medace we understand that purchasing expensive equipment is not always feasible during the early development of your products. That’s why we offer our specialized equipment for rent in our certified lab facility to researchers and companies. this includes; AMTI VIVO Joint simulator and Instron Electropulse E3000 fatigue testing system. Our team will help you set-up your experiments and train you to use the equipment safely and effective. They are always close if you need tips or additional support.
4. Expert advice
Our specialists in technical development, Quality Assurance and Regulatory work together with you and your team to ensure efficient and responsible product development when you need it.
5. Office space
With flex office spaces, dedicated workspaces and closed offices, a Scrum room and conference rooms, our coworking and flex office spaces can accommodate all your business tasks. Our offices are serviced to offer you a simple, smooth and frictionless start of every day.
6. Personnel support
Although our core task is to offer an environment where companies can learn to work independently, sometimes circumstances require you to temporarily hire external support to achieve your goals and milestones. Medace has specialized personnel available to perform services related to your (manufacturing) processes.
7. Cleanroom rental
ISO class 7 cleanroom facilities for rent to enable your clinical manufacturing. They are equipped, serviced and specifically designed to allow small scale manufacturing of Medical Devices. Your team will maintain in control of your manufacturing process, supported by Medace experts.
8. Quality Management (System)
Our ISO13485 certified overarching Quality Management system is at the heart of everything we do at Medace. It sets the requirements and criteria for the quality level of all elements you need such as infrastructure, equipment, training and personnel. Our team starts from Medace’s overarching QMS as backbone for your own QMS, thereby reducing crucial time and resources for fundamental elements of quality assurance.
Our facility
Medace is located in the heart of Europe in The Netherlands (Maastricht), just a stone’s throw from both Belgium and Germany.
