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Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience
Quality, compliance and regulatory officials at the three large device firms – along with their peers at Steris and CVRx – open up about appraisals conducted at their facilities under a voluntary US FDA pilot program that uses Capability Maturity Model Integration (CMMI) to measure the capability and maturity of their manufacturing sites. Along with providing a step-by-step walk-through of the assessments, the officials explain how a CMMI appraisal is nothing like a typical regulatory audit. They also talk about the types of benefits they're seeing (hint: cost-savings, and better manufacturing capability and quality), and how they network via monthly conference calls linked to the pilot. Also: Baxter Healthcare explains why it made its own maturity model, and how it plans to eventually replace the homemade tool with CMMI at all its facilities.
The third of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.
The largest medical device merger ever will not be materially impacted by the Treasury Department's new rules to thwart tax-inversion deals.
FDA has found that validation test data for three automated endoscope reprocessors – including Medivators’ Advantage Plus and DSD Edge, and Steris’ System 1E Liquid Chemical Sterilant Processing System – are adequate.
- Laboratory Testing Services
- Consumables, Central Supplies
- Infection Control-Sterilization
- Surgical Equipment & Devices
- Therapeutic Areas
- Infectious & Viral Diseases
- North America
- Parent & Subsidiaries
- Steris Corp.
- Senior Management
Walter, Jr. M Rosebrough, Pres. & CEO
Michael J Tokich, SVP, CFO
- Contact Info
Phone: (440) 354-2600
5960 Heisley Rd.
Mentor, OH 44060
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