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Regulatory Affairs Guidance for International Medical Device Compliance



For ISO / IEC 60601-1 Series


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Regulatory Affairs Guidance for Medical Devices and Medical Electrical Equipment



Market Access, Inspection, Certification and Product Marking Assistance



Our experienced team of regulatory affairs and product safety specialists work closely with designers and manufacturers, to help medical device manufacturers navigate the process of bringing a device to market. We are able to assist anywhere from the initial concept stage, through to the approved product gaining market access, and post market surveillance.


With years of industry experience, our medical device experts offer a bespoke service to assist medical device designers, developers and manufacturers to ensure your project advances in line with standards and regulations, and all aspects of the medical device regulatory approvals process.



MDR Guidance & PRRC



MDR (EU 2017/745)





Cranage Veritas has assisted clients towards achieving conformity to MDR (EU 2017/745) through all product life cycle stages involved with medical device development.​



For micro or small manufacturers we have the appropriate authority to provide a Person Responsible for Regulatory Compliance (PRRC) service, as outlined in Article 15 of the MDR (EU 2017/745).


About our PRRC Service

CE Marking



Technical File Review and Certification





We can assist with CE mark certification for electronic/ electrical equipment, systems, or devices, where necessary for EU market access.


Our team can prepare the necessary documentation and take responsibility for your product on the European market by signing the Declaration of Conformity.




Assistance with CE Marking and Certification

FDA 510 (k) Pre-Market Notification Guidance



For US Market Access





For medical device manufacturers looking to market their product in the United States, they will need to gain FDA market clearance. The first step in achieving this, is submitting an FDA 510(k) Pre-Market Notification.


This must be done at least 90 days in advance of bringing a device to market.​


Our medical device experts can assist you in the completion of your FDA 510 (k) submission, making the route to market access more efficient and easier to understand.


Assistance with 510 (k) Premarket Notification

Other Certification and Marking services



To a Range of Global Markets





We are able to assist the manufacturers, importers, or exporters of medical devices, in obtaining market certification for a range of global markets. The most popular of which include:

  • UKCA/UKNI Marking - For Great Britain and Northern Ireland.
  • CE Marking and Certification - For European Market Access.

View our Certification and Marking Services

Further Details on our Regulatory Guidance for Medical Devices



ISO/IEC 60601-1 Series



Our medical device guidance and advice services offer multiple solutions, from initial guidance at design concept, which helps to ensure compliance with IEC60601-1, through to achieving full regulatory compliance against the MDR.


Our range of Medical Device Guidance & Advice services include:

  • Quality system and regulatory compliance reviews.
  • Reviewing your product design prior to product testing.
  • Reviewing technical documentation, including risk assessments.
  • Reviewing or compiling technical files prior to submitting it to a Notified Body.
  • Assistance in preparation for FDA 510(k) Premarket Notification submission.
  • MDR Article 15 - Person Responsible for Regulatory Compliance.



How Our Guidance Can Help You


Call us today: +44 7484 225788
Or Request a Quote

Cranage Veritas



Info@cranage.ie

Cranage Veritas Limited
Suite 232 Airport House
Shannon Free Zone
Shannon
County Clare
Ireland
V14N578