Get ahead of the curve by achieving MedAccred audited output from a given process or product. OEMs and their suppliers will increasingly be required use MedAccred certified suppliers.
HOW IT CAN HELP
The MedAccred audit verifies a Medical Device supplier has the following:
- Critical process capability
- Necessary equipment
- Appropriate controls
- Qualified personnel
- Process validation
- Sub-tier controls
DETAILED DESCRIPTION
Just like MedAccred, the Nadcap program is administered by the Performance Review Institute (PRI). Nadcap was established in 1990 by SAE International. Nadcap’s membership consists of “prime contractors” who coordinate with aerospace accredited suppliers to develop industry-wide audit criteria for special processes and products. Nadcap certification is now required by all aerospace OEMs for metal finishing and treatment processes such as heat treating, welding, chemical processes, and coatings. MedAccred will eventually become the same type of required certification, which will be needed to quote all new work.
HOW MUCH DOES IT COST?
$5-10K fixed fee, depending on process
WHAT CAN I EXPECT?
Critical Process Assessment (Pre-Assessment Audit) is conducted to the MedAccred audit criteria used in an accreditation audit. The time for the Critical Process Assessment is the same as the accreditation audit, typically two to four days.
HOW TO GET STARTED
Sign up for a free consultation at: www.medmmap.org
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