Know more about CE mark Medical Device Certificate

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CE mark Medical Device Certificate Consultant

• Operon Strategist

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Information about CE Marking Certifications

• CE mark on a medical device or IVDs conforms that
  the device meets regulatory demand which is
  necessary to enter into the EU marketplace. A
  minor error in specialized file may delay your
  process of getting CE mark for a device. Boost
  your chances to get CE Marking Certification
  fluently with Operon Strategist.

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• CE mark Approval process will vary according to
  the Class of medical device, as per the MDR CE
  marking Approval correspond of few further things
  similar as product quality, technical dossier
  submission to NB, clinical evaluation and so on.
  numerous medical device manufacturers dont
  really read the regulations of EU MDR and they
  get stuck nearly in the process, which may delay
  the project to avoid that you need to know where
  to start and who's right CE marking consultant
  for you.
• Operon strategist dont leave you before, we make
  sure that our customer should get the CE approval
  with minimal efforts. We've a well- experienced
  staff of expert engineers and significant
  knowledge and familiarity with the CE marking
  process. We've a wide knowledge of safety
  standards, product safety assessments, product
  design and the real- world issues faced by the
  manufacturing industries. Our CE Mark Consultant
  assists new medical device manufacturers to
  launch a new device into the EU market.

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Why do you need CE Marking?

• Short answer is, you get to sell in further
  countries globally thereby adding your footmark
  exponentially and also it helps in building
  credibility within doctors community in India.
  Every country follow their own regulatory system,
  for eg USFDA is for dealing in the US. CE Mark is
  mandatory to sell medical devices within any of
  the 32 European Union countries. It also
  validates that your device comply with all
  regulations put forward by European Union, which
  is accepted by numerous other countries too.
  However CE mark is accepted by numerous countries
  and hence investment can be justified fluently.

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Medical Device Directive is one of the most
complex directive and one which involves strict
alert by the European Authorities. way for CE
marking for Medical Devices of Class 1s, IIa, IIb
and III are as follows

• Apply a quality operation system ISO 134852012 as
  per annex II V of MDD( not needed for class I
  non sterile non measuring devices).
• Appoint an European authorized representative(
  needed by non EU manufacturer only).
• Apply General product specific norms as
  applicable to the medical device
  particularlyBio-compatibility( ISO 10993 series
  for Implants and IEC 60601 series for
  Electromedical products).
• Prepare a technical file comprising of detailed
  manufacturing process, devices description, test
  reports, risk analysis, Instruction for Use,
  labeling, applicable normsetc.
• Submit the specialized file QMS documents to
  notified body for approval.
• Notified Body conducts onsite inspection through
  approved adjudicators.
• Restate IFUs labels to the original language of
  the country to which you want to export.

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Operon Strategist

• For more information about Medical Device
  Regulations
• please feel free to contact enquiry_at_operonstrate
  gist.com
• Or Visit https//operonstrategist.com
• Call Us Now
• 9028043428 9370283428 9325283428
• Address
• Office 14, 4th Floor, MSR Capital,
• Morwardi Road, Pimpri Colony, Pimpri, Pune 411018

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