Our capabilities
Design R&D
Our dedicated R&D teams include designers, engineers, and ergonomics specialists able to develop innovative, functional, and user-centric products that meet the needs of both our customers and the end users. Our innovation process starts at the core of healthcare, with secondary and primary research to understand patient journeys, monitor market trends and identify opportunities.
Some of our key R&D capabilities include:
- Ergonomics and human factors studies
- Concept industrialization
- Design to cost
- Product life cycle analyses
- Fused Deposition Modeling (FDM) prototyping
- Design to value
Our methodology
Regulatory
SGH Medical Pharma has a track record of 135 CE-marked devices, a DMF submission to the FDA and is in the process of applying to UKCA.
We draft all technical documentation for CE marking ready for our customers to register and keep it up to date in line with regulatory amendments. We also prepare for Intellectual Property (IP) transfer by drafting patents and trademarks, and guide our customers through change controls.
Quality
Quality management involves controlling every stage of the process, from identifying the customer’s requirements to shipping, including development, process characterization and manufacturing. Our quality control management system ensures compliance with the standards and regulations for medical devices and primary packaging throughout the product life cycle, in every aspect of our business (ISO 13485 and ISO 15378 certifications, as well as ISO 14001). Our referencing pre-audits and audits processes are always successful.
Industrialization
Our industrialization center develops, refines, and implements special machinery such as assembly and inspection machines, automated islands, marking machines, etc. It designs, develops, and optimizes the industrial facilities to respond precisely to requirements and ensure perfect adaptability to the product and its assembly. This in-house expertise allows us to manufacture tailor-made items, but also to manage costs to contribute to your success.
Our controlled-environment production areas are designed for lean manufacturing and provide high-speed production. We have ISO 8 – ISO 7, DNA RNA free cleanrooms, fully automated assembly workshops (including marking), as well aswrapping/finishing packaging lines, all continuously improved to maintain a high level of quality and performance.
