Renting R&D Space
Renting our comprehensive facilities
To assist with product design and development verification.
Design Developmental Manufacturing Service
In addition to our existing contract manufacturing services, this offering is suitable to clients who are undertaking advanced stage Research and Development (R&D) work on new medical devices and require the facilities and services of a regulated manufacturing service, but are not yet ready for commercial manufacture.
This service offers you the opportunity to continue to develop your product and manufacturing methods with the input of an accredited ISO 13485:2016 manufacturer to ensure there are no costly or time consuming obstacles once you are ready to transfer to commercial manufacture.
Design and Development Validation
When developing a medical device, design and development validation must be performed to ensure the product is capable of meeting the requirements for the specified application or intended use.
By using Europlaz’s comprehensive facilities, design validation can be conducted on representative product which can include initial production units, batches or their equivalents.
Work within our facilities to perform clinical evaluations or performance evaluations of the medical device in accordance with regulatory requirements.
Validation must be completed prior to release for use of the product to the customer and records and results of the validation maintained.
Facilities
The facilities we have available to rent include:
- Dedicated R&D laboratory space with access to assembly and measurement equipment including injection moulding, ultrasonic welding, bonding and 3D printing.
- Access to our select group of engineering partners.
- Transitory cleanroom environment where initial batches of product can be manufactured under our ISO13485 QMS for use in preliminary trials, design validation/verification and showcasing events.
All of the above is supported by our internal team of project engineers who bring years worth of experience with them in medical device manufacturing and assembly methods.
Transfer to Manufacturing
Once your product and processes have been fully developed, you will be ready to quickly transfer the process into our manufacturing facility. Safe in the knowledge that there will be no time or cost hurdles for you to overcome to manufacture your product.
Why not book in a telephone meeting with us to learn more about our service offerings? Use the meeting scheduler below and select a covenient date and time.
Alternatively you can contact us by telephone or email.
