- +353 (0)91-896900
- [email protected]
Q_EN_ISO13485
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Concept Development
During the concept development phase, products are clearly defined. Proxy Biomedical will develop a concept design according to a client’s brief or refine an existing client design for prototype development. From intended indication for use, to preferred features, this requires an examination of the commercial opportunity, predicate devices already on the market, patent landscape and definition of product specifications. At this phase of the design process, every aspect of the product is open for discussion and anything is possible. However even at this early stage, consideration of the design for volume manufacturing is taken into account.
Volume Manufacturing
Proxy Biomedical offers high quality and flexible manufacturing solutions for finished devices and biomaterial components. We partner with some of the world’s largest OEMs and smaller emerging medical technology companies and maintain production facilities to produce volumes from custom-builds, right up to large-scale lean manufacturing.
Our manufacturing facilities are certified to ISO 13485:2012 and registered with the FDA, while our Quality Management System (QMS) complies with the Japanese MHLW. Our development processes ensure lean methodologies are designed into the product and our manufacturing engineers provide continuous process improvements through the product lifecycle.
Production Transfer & Pilot Manufacturing
During this phase product design specifications are transferred to production and the production processes are established to support volume manufacturing. Following process validation, the manufacturing of commercial product can commence in our GMP controlled Class 8/Class 100,000 cleanroom facility, scaling up to meet commercial volume requirements.
The transfer to production activities include: *outsourced
Clinical & Regulatory Support
Proxy Biomedical can provide a comprehensive regulatory compliance consulting service to its customers, including:
Tel: +353 (0) 91-896900
Prototype Development
To facilitate rapid prototyping Proxy Biomedical offers a dedicated R&D materials laboratory, along with a substantial inventory of resorbable and non-resorbable materials. Our research, design and development personnel create concept prototypes, for evaluation and testing. Prototype production is undertaken in a controlled environment, leveraging our biomaterials conversion processes. This is followed by characterisation of prototypes to the appropriate international testing standards, forming the basis of product engineering specifications. Testing may include:
*outsourced
Product Development
Proxy Biomedical provides customers with a verification and validation management service to help them meet the challenge of FDA and MDD directives:
*outsourced