The electropolishing process cleans and polishes various metals in
a special electrochemical solution. An electrical current passes
through a chemical bath that dissolves a small amount of metal from
the surface, leaving a smooth, shiny finish. Besides removing
necessary material and providing high luster, the electropolishing
process also allows the following:
· removal of stress risers
· corner rounding
· edge sharpening
· deburring
· removal of heat effected zones and micro-cracks
· improves the product's fatigue life
Our electropolishing process is customized for micro parts. It
utilizes custom designed acids to remove metal and enhance the
surface for each medical grade alloy, such as:
· Stainless Steel
· Titanium
· Platinum
· NiTinol
Facilities:
· Mini ultrasonic cleaning machines
· Mini temperature-controlled electropolishing machine
· Titanium basket and rack
· Dry oven
Quality Assurance
Jenitek is committed to supplying products and services that meet
the needs of customers, comply with statutory and regulatory
requirements, increase customer satisfaction and maintain the
effectiveness of the quality management systems through continuous
improvement in products, processes and services.
Jenitek's quality management system has been certified ISO
13485:2012 and ISO 9001:2008 in order to fulfill each of our
customers' specific requirements. FDA's QSR 21 CFR PART 820 and EU
MDD 93/42 EEC certifications are in process.
We have a thorough quality system including four levels of
documentation including manuals, procedures, work instructions and
records. According to system documentation and processes, our
quality activities such as production, inspection, product
development (NPI), process validation, supplier chain control, and
continuous improvement are controlled. This means we can deliver
precision, performance and safety products and services to our
customers around the world.
6 Sigma Quality Team The Jenitek quality team understands these system standards are not
only the foundation of quality management but also paramount to the
importance of our medical products, customers and product
development, production, and improvement process. We have extensive
experience with quality management and use a range of methods and
tools, including IQ/OQ/PQ, FMEA, PFMEA, and Design of Experiments
(DoE) to support in product development and improvement processes.
Packing and Tracing
Products with validated sterile packing. Specifically configured to
meet stringent packing validation requirements.
Certification
ISO 9001:2008 Certified
ISO 13485:2012 Certified
ISO 14001:2004 Certified
OHSAS 18001 Certified
FDA 21CFR 820 In-Process
EU MDD 93/43 In-Process
ISO 14971 2004 Compliance
