Medical Device Certification - ISO 13485 | Operon Strategist

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ISO 13485 - QMS Medical Device Certification

• Operon Strategist

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What's ISO 13485 Quality Management System ?

• How do you manage your Quality Management System?
  If you're like the majority of the medical device
  industry, chances are you have a QMS that's a
  combination of paper- based processes and general
  purpose tools, approximately held together by a
  group of people within your company-- generally
  document control.
• Its important because it's long overdue with the
  former interpretation being released 13 years
  before in 2003.
• The 2016 standard is veritably much a bridge.
  What I mean is that this bridge explicitly
  describes and defines current QMS prospects for
  medical device companies. Prior to these advances
  being formally defined and documented in the
  standard, numerous of the best practices being
  advised and adopted were veritably ad hoc in
  nature and frequently sounded to be based on
  auditor opinions.

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• Medical device manufacturer should appoint an
  experienced ISO13485 consultant who can work on
  all risk class devices. The associations need to
  cover the safety and risk information during
  product life cycle as per ISO 13485 demand. As an
  ISO 13485 medical device consultant, Operon
  Strategist identify the specific regulatory
  demand for the product similar as MDR, FDA 510(
  k) during the perpetration. This helps
  manufacturer in the further process of CE mark
  medical device or FDA 510( k) clearance.

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Key elements of an ISO 13485 Quality Policy

• Adapt the policy to the association.
• Define a frame for setting your quality objects.
• Establish the commitment to meeting all
  conditions.
• Establish the operation commitment.
• Communicate the Quality Policy.
• insure the regular review of the Quality Policy.

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