MedAccred Awards First Accreditation in Sterile Device Packaging
QTS recently received accreditation from MedAccred in Sterile Device Packaging.
MedAccred is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain. Why MedAccred? In today’s world of global manufacturing, the supply chain is mul...
MedAccred is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain.
In today’s world of global manufacturing, the supply chain is multi-tiered and geographically remote, making oversight challenging and costly. To prevent output deficiencies, critical processes and products must be validated during manufacturing to prove that they are fit for purpose, satisfy regulatory requirements and reduce overall risk. Download the MedAccred Brochure
- Provides consistent/standardized critical process accreditation accepted by the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
- Conducts in-depth critical process audits that are compliant and consistent to accepted industry/technical standards and conducted by Subject Matter Experts
- Provides greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, ISO 13485, MDD, etc.)
- Improves flow down of OEM requirements to sub-tier suppliers
- Medical device industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost.
MedAccred Audits Coming to Medical Device Industry
Ed Engelhard of Solar Atmospheres Inc. talks to MTI TV
In this video, Ed Engelhard, Vice President of Corporate Quality at Solar Atmospheres, discusses the MedAccred program with MTI. Focused on heat treaters serving the medical device industry, this interview shares information on the MedAccred audit process. Solar Atmospheres was the first company in the world to obtain MedAccred accreditation for heat treating.
How does it work?
Audits are conducted on behalf of its subscribing OEM members using collaboratively created audit criteria. The accreditation is granted and accepted by the program’s subscribing OEM members. The audit criteria incorporates industry accepted performance standards and manufacturer specifications that meet the requirements of the regulator.
Process-focused Product Audits are conducted by industry approved and trained SME auditors, who have extensive experience and knowledge of their process.