PDXpert PLM simplifies compliance with device and materials 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.
Learn more about how PDXpert PLM manages your engineering data
PDXpert PLM has been specifically designed for smaller
organizations whose documents, parts and bills of materials must conform
to regulatory and contractual requirements.
We invite you to:
Make compliance software a priority today, and reap the rewards of fast,
accurate and reliable regulatory agency compliance!
Register now to download a free
evaluation copy of PDXpert
PLM software for your regulatory compliance needs.
1. Directive 2002/95/EC of the European Parliament and of the
Council of 27 January 2003 on the restriction of the use of certain
hazardous substances in electrical and electronic equipment (RoHS);
Directive 2002/96/EC of the European Parliament and of the Council
of 27 January 2003 on waste electrical and electronic equipment
(WEEE)
070802.1945