Case Study: Transferring a Medical Device to Volume Manufacturing
By Mo Ohady, General Manager, Digicom Electronics
Excitement builds in new product development when the product can move from the lab or small volume manufacturing to a high volume manufacturing environment. High volume manufacturing can be done by the company that developed the product or it can be transitioned to a contract manufacturer. Because equipment and processes often have to be adjusted or changed to accommodate the higher volume and/or speed, problems can arise that hadn't been anticipated.
Process Validation 101
by Anne Bynon, MSBE and Fariba Hurry, MS
Introduction
Process validation ensures that a process consistently produces a product that meets its specifications. It is an important component in the design, prototyping and manufacturing process and one, if done correctly, that can save a considerable amount of time, money and resources. This paper describes why a process requires validation, the three primary steps of process validation, and a common mistake to avoid in documentation.
Digicom Highlights ROACH at Pacific Design
Digicom Electronics will highlight the collaborative process involved in producing a reconfigurable open architecture computer hardware (ROACH) system at Pacific Design & Manufacturing/MDM West 2011, in booth #3880. Digicom collaborated in the design, development, prototyping, sourcing, manufacture and test, and produced the finished, fully-compliant product. The system was developed for space science and research applications.
BusinessWire - Digi-Com Electronics Achieves Certification to ISO 9001:2008 and ISO 13485:2003
Electronics Contract-Manufacturer Digi-Com Electronics Receives Certifications for Its Operations Adhering to Internationally-Recognized Standards for Quality Management
RICHMOND, Calif.--(BUSINESS WIRE)--Digi-Com Electronics was recently presented with its ISO 9001:2008 and ISO 13485:2003 certificates from Intertek, affirming that Digi-Com’s operations adhere to internationally-recognized standards for quality management.
EMSNow - New manufacturing relationships form as economy rebounds
By Pamela J. Gordon, on the Technology Forecasters BlogOct 15, 2009
As the economy rebounds and electronic-product companies' (OEMs') requests for manufacturing-outsourcing proposals increase once again, some supplier-customer matches will be made haphazardly. This is a concern of executives at small and large contract-manufacturing companies, as well as at the OEM customers.
Let's start with a small
electronics-manufacturing services (EMS) company example. I've known Mo Ohady since 1982 - the year he started Digi-Com Electronics down the road from TFI's headquarters. He'd called to ask questions about an article in which I'd been quoted. We started to meet for lunch every few years, and last month I was delighted to hear that Digi-Com received certification to ISO 9001 (quality management) and ISO-13485 (bio-medical devices).
