Other
Details:
- • ISO 13485 is an international standard that represents
the requirements for a comprehensive "management
system for the design and manufacture of medical
devices".
- • The primary objective of the standard is to facilitate
harmonized quality management system requirements
for regulatory purposes within the medical device
sector.
- • ISO 13485 follows the process approach that ISO
9001:2008 establishes and compliance take the form
of updates.
- • ISO 13485 provides a basis to effectively manage
legal and regulatory requirements compliance as
these are invoked by the USA FDA and equally EU
CE medical device directives and equally other
countries with due care.
- • ISO 13485 requires that we monitor organizations
through on site assessment of an organization's
regulatory requirements and legal obligations.
- • Benchmarking of ISO 13485 provides recommendation,
and thus granting a certificate confirms that the
organization's management system meet its regulatory
requirement and legal obligations with due care.
- • This means that certification of a management
systems carries impartiality and competence to
fulfill accreditation requirement whether regulatory
requirement legal obligation or contractual agreement
with due care.
Benefits:
- • Ensure compliance with the requirements of the
standard and more
- • Streamline your processes, increasing efficiency
resulting in significant time and cost savings
- • Gain a competitive edge with our independent,
globally recognized third party certification
- • Benefit from using a single source for all your
testing and certification needs
- • Take advantage of our wealth of international
experience, expertise and global presence in the
medical devices market.
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