Quality Assurance & Sterilization
Accellent engineers are adept at identifying ways to improve quality from the ground up. We are constantly training and equipping our engineers with industry best-practices, Lean Engineering principals and Six Sigma methodologies.
Quality System
The Accellent Quality System outlined in the Quality Manual complies with the following standards:
- International Standard ISO 13485
- International Standard ISO 9001
- FDA Quality System Regulation (QSRs) 21 CFR 820
- European Community Medical Device Directive (MDD) 93/42/EEC
The Accellent Quality System ensures customers receive the same high standards with respect to quality results, regulatory compliance, systematic monitoring and continuous improvement throughout Accellent. While remaining in compliance with FDA and ISO requirements, we maintain flexibility within our system to accommodate our customer's quality needs.
TÜV Product Service is the world leader in medical device certification and is the Quality System registrar
for Accellent. All Accellent facilities are registered under one certificate with TUV Product Services; this
integration allows Accellent to standardize design procedures, reduce inspection cost and minimize auditing activities for our customers.
Accellent and all of its employees are committed to the highest standards of quality, delivery, and service of our products to all of our customers.
Lean Engineering/Six Sigma
Like karate, engineering requires focus and vision. Partnering with Accellent means partnering with individuals devoted to improving the quality of their work. Accellent engineers have the opportunity to develop their vision through six-sigma training, learning to improve efficiency, eliminate waste and sustain quality.
Lot Release Testing
Accellent engineers are experts at rigorously testing your devices under the widest variety of conditions. Our exhaustive testing ensures that your product hits the market with the highest level of quality.
Sterilization Management
Accellent leverages multiple partner relationships to provide a complete sterilization management solution. Further, our engineers are adept at providing industry-standard sterilization validation solutions for our customers.
FAQs
Does Accellent provide sterilization services?
Accellent has strategic relationships with a number of well-respected sterilization contractors. Accellent routinely performs sterilization validations and manages device sterilization across EtO, gamma and E-beam sterilization methods.
Can Accellent perform sterilization validation?
Yes, Accellent routinely performs sterilization validations on behalf of our customers.
Can Accellent perform aging studies, transportation studies, etc.?
Yes, Accellent Engineering Services routinely performs various studies and analyses supporting new product releases and transfers. Please inquire as to your specific requirements.
Accellent Features
Accellent Industrial
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