Identifying future medical devices

Leading medical device developer and manufacturer Lucid Group is now using in-house laser capabilities to comply with regulation requiring indelible unique device identification (UDI) on difficult to mark silicone and polymer film wearable and invasive components. Based at Manchester Science Park, Lucid is an integrated team of industrial and UX designers, electronic and software engineers, research, manufacturing and compliance specialists. Since 2002 they have supported organisations to innovate; focused on development and delivery of products and services for healthcare, pharma and hazardous environments. Unique device identification is an existing requirement of FDA medical device regulation for most medical devices. FDA regulation will extend to low-risk, class I devices on September 24, 2020. The EU Medical Device Regulations 2017/745 - medical devices has similar requirements. Although the EU deadline for compliance was recently extended to May 2021, UDI compliance is problematic for many manufacturers. As Jan Hon Wong, Lucid’s Head of Regulatory Affairs, comments: “Reliable, individual marking of hard-to-adhere-to surfaces, particularly when disinfected with harsh chemicals, is a key priority. Conformable materials, such as silicones and polymer films, offer critical performance properties in the wearable and invasive products we’re involved in developing every day.” Lucid’s team has successfully developed a laser cutting capability to etch UDIs as machine readable data matrices, codes and other markings required in new regulation. Manufacturing capabilities include marking silicone over-moulded electronics and film parts that have undergone biocompatibility testing to ISO 10993 for invasive applications. Lucid’s use of UDI extends beyond compliance. Data matrices are scanned into connected devices, to activate and monitor secure medical device system use, providing traceability and commercial benefits. Jan continues: “Lucid could help other organisations with similar challenges, providing acceptable evidence of equivalence to accelerate regulatory compliance”. Accredited to ISO 13485 for medical device development and manufacturing, Lucid Group is the ideal concept to scale-up medical device development partner for agile organisations. To request a more information please contact Lucid Group Limited on + 44 (0) 161 860 0058 or email ideas@lucidinnovation.com

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Brochure: https://evessio.s3.amazonaws.com/customer/264700c5-b712-4059-a7b0-482612692018/event/53190266-c579-4fee-9ddc-299817dd24be/responses/00adfbb0-9597-4b10-acf1-920465dfe83d/Lucid_brochure.pdf

 


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