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Device Advice & CERs offers a wide range of services to a wide range of customers from small newcomers to medium and large established firms.

Regulatory Advice

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Device Advice & CERs offers advice on a wide range of subjects such as:

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  • Regulatory Basics for small companies & start ups
  • Device Classification (and upcoming changes)
  • Australian (TGA) Approvals
  • CE Marking/MDR
  • Clinical Evaluation & Clinical Evaluation Reports
  • Post Market Surveillance

Regulatory & Medical Writing

Device Advice & CERs has expertise in regulatory and medical writing of documents such as:
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  • Clinical Evaluation Reports (CE, TGA, CFDA)
  • Clinical Evaluation Plans (MDR)
  • Regulatory Submissions & Responses
  • Technical Files & Design Dossiers
  • Regulatory Plans
  • Procedures

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Documentation Editing & Quality Control

Let Device Advice & CERs help to edit your documents and QC them to ensure that you meet regulatory requirements such as: 
 

  • Clinical Evaluation Reports
  • Procedures; PMS, PMCF, CERs
  • Technical file/Design Dossier documents
  • Information for Use 
  • Patient Information Guides
  • Marketing Material/Websites

Training

Is your company struggling to get its head around medical device regulations, are you tempted to enter Europe or Australian markets? Would you like a fresh approach to training your staff? Device Advice and CERs can provide individualised training on a wide range of subjects such as:
 

  • Regulatory Basics for small companies & start ups
  • Device Classification 
  • Australian (TGA) Approvals
  • CE Marking/MDR
  • Clinical Evaluation & Clinical Evaluation Reports
  • Post Market Surveillance
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