Issue link: https://iconnect007.uberflip.com/i/622045
50 SMT Magazine • January 2016 All employees were trained on the require- ments and procedures, and internal audits per- formed to ensure organization compliance. Las Marias: Are there regulatory standards/com- pliance issues you have to comply with? Morrison: ISO 13485, Food and Drug Adminis- tration (FDA) 21 CFR Part 820 Quality System Regulation and Medical Device Directive 93/42/ EEC (European Union) are the primary stan- dards we comply with. Las Marias: Among the many challenges today when it comes to electronics products are reliabil- ity, complexity and sophistication, more so with the medical electronics market, while meeting the many regulatory requirements in the sector. please give your comments here. What strategies do you have in place to address these challenges? Morrison: Medical electronic product is becom- ing increasingly complex due to the increasing complexity of electronic circuits; power require- ments; introduction of new component and material technologies; and the introduction of less robust components. To meet these challenges, as an EMS partner to our customers, we collaboratively work with our customers to perform design reviews at key stages throughout the design cycle. This early supplier engagement provides critical feedback to address potential issues to ensure a success- ful new product introduction and high-quali- ty, high-yielding, reliable and manufacturable product. About 80% of the design cost and risk decisions are made during the first 20% of the development cycle. Strategies including DFX (Design for Excellence) and leveraging our technical services group to develop solu- tions and alternates have mutually benefited both our customers—by providing a higher quality product—and SMTC, in producing a more robust and repeatable manufacturing process. FEATurE inTErViEw MEDICaL ELECTrOnICS: rISkS anD OPPOrTunITIES FOr ELECTrOnICS ManuFaCTurErS