-
- News
- Books
Featured Books
- smt007 Magazine
Latest Issues
Current IssueBox Build
One trend is to add box build and final assembly to your product offering. In this issue, we explore the opportunities and risks of adding system assembly to your service portfolio.
IPC APEX EXPO 2024 Pre-show
This month’s issue devotes its pages to a comprehensive preview of the IPC APEX EXPO 2024 event. Whether your role is technical or business, if you're new-to-the-industry or seasoned veteran, you'll find value throughout this program.
Boost Your Sales
Every part of your business can be evaluated as a process, including your sales funnel. Optimizing your selling process requires a coordinated effort between marketing and sales. In this issue, industry experts in marketing and sales offer their best advice on how to boost your sales efforts.
- Articles
- Columns
Search Console
- Links
- Events
||| MENU - smt007 Magazine
ESCATEC Achieves FDA Registration as Medical Device Contract Manufacturer
July 20, 2015 | ESCATECEstimated reading time: 1 minute
ESCATEC Medical Sdn Bhd, part of the ESCATEC Group based in Penang, is now FDA registered as a Medical Device Contract Manufacturer under FDA 21 CFR Part 820 QSR (registration number 3010354240). The company has already been approved to the ISO13485 quality management standard for medical device manufacturers for a number of years.
Markus Walther, ESCATEC's CEO, said, "Quality, safety and traceability are vital for medical devices. The ESCATEC Group is renowned for its quality and precision, which is why companies come to us for innovative solutions to design challenges and quality manufacture that they can trust to put their brand on. FDA registration for the manufacturing of medical devices is mandatory for products that are marketed in the USA and is globally recognised as a sign of manufacturing excellence and quality, opening up the world market for our customers."
The FDA registration implies that ESCATEC Medical Sdn Bhd has necessary management, production and process controls for ensuring that products produced meet the necessary safety and quality requirements for the US medical device market. It further implies that the corrective and preventive actions meet the expectations of the FDA. ESCATEC's long-standing focus on quality means that it already has robust systems in place for component sourcing, robust production processes including in-depth product testing.
ESCATEC provides a fully integrated, product design and manufacturing service that covers every stage from taking the initial idea for a product through R&D to product design, prototyping and then volume production in the company's Asian facilities. This integrated approach ensures that every step of the process dovetails together and that products are designed for manufacture from the very start during Design and Development.
About ESCATEC
The ESCATEC Group provides fully-integrated electronic and mechatronic design and manufacturing solutions to assist customers in achieving success in their market. Its completely integrated and best-in-class service enables companies around the world to operate more profitably, sustainably and efficiently. Founded in 1984, its history is full of innovation, which makes it a first choice partner for international OEMs. The company perfectly blends the latest business practices, attention to quality, precision and detail, and the advantage of low-cost, mass-volume manufacturing capabilities in its Asian factories.
Further information about ESCATEC, a leading provider of contract design and manufacturing services: www.escatec.com; enquiries@escatec.com
Suggested Items
GlobalFoundries Commits to Achieving Net Zero Emissions and Carbon-Neutral Power by 2050
04/23/2024 | GlobalFoundriesGlobalFoundries (GF) is furthering its commitment to sustainable operations and fighting climate change with the announcement of two new long-term goals to achieve net-zero greenhouse gas (GHG) emissions and 100% carbon-neutral power by 2050.
ROHM Group Company SiCrystal and STMicroelectronics Expand Silicon Carbide Wafer Supply Agreement
04/23/2024 | ROHMROHM and STMicroelectronics, a global semiconductor leader serving customers across the spectrum of electronics applications, announced today the expansion of the existing multi-year, long-term 150mm silicon carbide (SiC) substrate wafers supply agreement with SiCrystal, a ROHM group company.
IDTechEx Report Unveils 3D Electronics Status and Opportunities
04/22/2024 | PRNewswire3D electronics is an emerging manufacturing approach that enables electronics to be integrated within or onto the surface of objects. 3D electronic manufacturing techniques empower new features, including mass customizability, greater integration, and improved sustainability in the electronics industry.
Altus Group Helps BitBox Unlock Productivity and Efficiency Gains with New Reflow Oven
04/22/2024 | Altus GroupAltus Group, a leading provider of capital equipment, has recently assisted BitBox, a UK-based electronics design, engineering and manufacturing company in upgrading its operations with the implementation of a new reflow oven from Heller Industries.
Growth Potential: Electronics Manufacturing Driving Massive Surge in Manufacturing Investment
04/22/2024 | Shawn DuBravac, IPCIn the early months of the pandemic, investment in manufacturing infrastructure, such as plants and production facilities, declined sharply. Real investment dropped over 11%, before finally recovering to pre-pandemic levels in the first half of 2022. Over the past two years, however, several factors have combined to drive manufacturing investment to record levels.