Accelerate your medical innovation
The Medace model enables sustainable development and manufacturing resulting in greater efficiency.
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.
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 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 GMP or ISO cleanrooms with supporting infrastructure, R&D labs and 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
Contact us to discuss how we can support your development.
Our facilities
Medace offers on demand GMP and ISO cleanroom rental, laboratory rental and specialized equipment for emerging companies and academic groups at our 2100 square meter facility. While our core focus lies with companies developing ATMPs and Medical Devices we also support other medical area’s.
The fully-equipped Tissue Culture and Chemical R&D labs provide a controlled environment for the development and optimization of your product while reducing capital expenses. Equipment, consumables and support are all available.
The capabilities consist of;
- 4 GMP grade C & 2 GMP grade B and 5 ISO class 7 cleanrooms w. QC-rooms
- Development laboratories & controlled warehousing
- Office and meeting space
Explore your new R&D and manufacturing facility online.
Quality support
Medace has dedicated in-house teams of Quality Assurance experts to 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. 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.
- Qualified Persons for product release
- Quality Assurance experts to support your development
- Ready-to-use templates, work instructions and procedures in place
- Develop your own and product-specific QMS
More information about Quality Management.
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 product 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.
- 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 products. As these products can be 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
- 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.
Our services and products
1. R&D labs and equipment
Medace offers fully-equipped flexible chemical and 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 medical 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 product development.
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. 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
GMP grade B and C and 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 Cell based therapeutic products, Advanced Therapy Medicinal Products (ATMPs) and 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.
