ISO 13485 Certification

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ISO 13485 Certification Quality System for
Medical Device 

• For details visit Here http//www.ursindia.com/is
  o_13485.aspx

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ISO 13485 Certification

• We provide ISO 13485 certification, an
  international standard that defines quality
  management system (QMS) requirements for
  manufacturers of medical devices. The primary
  objective of the standard is to facilitate
  harmonised QMS requirements for regulatory
  purposes within the medical device sector.

For details visit Here http//www.ursindia.com/is
o_13485.aspx
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ISO 13485 Requirements

• In order to achieve ISO 13485 certification, you
  must
• develop written policies for the following
  functions
•      Document and record controls
•          Internal auditing procedures
•          Controls for non-conformance
•          Corrective and preventative actions
•          Process and design controls
•          Record retention
•          Accountability and traceability

For details visit Here http//www.ursindia.com/is
o_13485.aspx
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 Planning the Quality System

• ISO 13485 Standard includes a requirement for
  Quality Planning. Writing a Quality Manual is not
  sufficient to meet this requirement. You need
  documented Quality Plans for implementing changes
  to your Quality Management System, and creating a
  new Quality System from scratch is a big change.
  There is no required format for quality plans.
  Spreadsheets and Gantt Charts are the most common
  tools for quality planning.

For details visit Here http//www.ursindia.com/is
o_13485.aspx
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How is ISO 13485 recognized worldwide?

• ISO 13485 focuses on the harmonization of the
  Quality Management Systems in the framework of
  Medical Device regulatory requirements. It is not
  surprising to see that many jurisdictions
  recognize or even require that Medical Device
  manufacturers obtain ISO 13485 certification in
  order to access their market.

For details visit Here http//www.ursindia.com/is
o_13485.aspx
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Contact details

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• F-3, Sector 06 Noida- 201 301,NCR Delhi,
  IndiaTel-91-120-6404223 - 26,Tel[phone]
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