PLM ensures compliance with regulatory requirements
It's a world of regulations
Obviously, regulatory mandates and contractual requirements simply can't be ignored.
Medical device manufacturers must comply with governmental agency standards, such as
Food & Drug Administration (FDA) 21 CFR Part 820, and commercial standards for medical
devices, such as ISO 13485 and UL 60601-1. Supply chains must conform to environmental
regulations, such as the European RoHS and WEEE directives1, and the automobile industry's
waste management initiatives ("ELV").
Even in industries unaffected by these regulations, customers are increasingly
negotiating recognized configuration management practices, such as ISO 10007 and
ANSI/EIA-649, into their supplier contracts.
PDXpert PLM helps meet your obligations
A product lifecycle management (PLM) system can help manage your 21CFR820 device
master record (DMR) by supporting identification and traceability, facilitating your
control of nonconforming product, documenting preventative actions, and otherwise
enhancing the quality system record.
PDXpert PLM supports RoHS/WEEE/ELV compliance with features such as materials
identification (including reporting thresholds and CAS number), assembly material
mass (weight) roll-ups, and Material Declaration reporting (% and PPM) for any
physical item or assembly.
These capabilities translate directly into real benefits including increased
sales revenue through faster product releases; lower product costs by using more
accurate BOMs; and lower administrative overhead by providing important compliance
reporting automatically.
Discover how PDXpert PLM can help reduce the expense
of regulatory compliance. We invite you to: