CONSULTANTS FOR CLINICAL EVALUATION DOCUMENTATION

Over the past two years we have heard hundreds of top officials and QA/RA regulatory managers talk about the updated  MEDDEV 2.7/1 Rev 4 and arrival of new MDR and its impact and complexity on both during Notified Body surveillance audit and new CE Application.

With this dilemma in mind, we think it’s important for top officials  and managers to have a strategic framework that they can use external consultants to address complexity in MDR 2017/745 & MEDDEV 2.7/1 Rev 4. So to that end, we would like to offer a simple strategy ”handover the CER project we will take care” . While we present below features you will understand easily why manufactures depend on us “true sourcing partner in medical device regulation”.  it’s also important not just a one time project for us, it’s for years!!!

  • Any device of any risk class and type our qualified, efficient and experienced team based in Bangalore, India will take up each project and handle with upmost dedication and passion supervised by team leads and project heads. Day to day activities done in cloud which makes easy for clients across the world to understand and guide the missing information.
  • We are not just consulting!!. We guide, We create, We review and submit documentation to Notified Body. Still not over. We manage, we answer to notified body if any review comments and we do resubmission if required. We will not ask or allow client team to handle the documentation until we finish the job.  We only need proper information from client.
  • Qualified, efficient and experienced team based in Bangalore, India will take up each project and handle with upmost dedication and passion supervised by team leads and project heads. Day to day activities done in cloud which makes easy for clients across the world to understand and guide the missing information.
  • Last but least; Economic pricing and super fast delivery.  You are welcome with a Clinical Evaluation Project and check how we different from others.

Read more >>

CLINICAL EVALUATION (MDR / MEDDEV 2.7/1 REV.4)

Clinical Evalaution

Medical device Manufacturers of all risk class and type must clinically evaluate the device safety and performance before applying for Notified Body for CE Marking. To conduct clinical evaluation as per MDR Article 61, the manufacturer has to examine clinical data sourced from various sources in order to conclude the subjected medical device is safe and performing good for the intended purpose.

The clinical evaluation of a medical device extends throughout the entire life cycle of the device and its becoming a tough challenge for the manufactures to maintain and orderly arrange the documents.

Read more about Medical Device Clinical Evaluation >>

CER Literature Search & Consultation Service >>

CLINICAL EVALUATION REPORT

Clinical Evalution Report

EU commission released to MEDDEV 2.7/1 Rev 4 and IMRF N41 guidance document before the arrival of EU MDR article 61. Both guidance documents are legally not binding.

Clinical Evaluation Report must document important aspects such as scope of the clinical evaluation, description of the medical device, state-of-the-art in science and technology as well as clinical background, and route of clinical evaluation for the device under evaluation.  

Clinical Evaluation Report must be updated on routine intervals.  The manufacturer has the right to monitor PMS, PMCF, PSUR activities and status of the risk management strategy  to determine when to update the Clinical Evaluation Report.  Notified Bodies during routine surveillance reviewing clinical evaluations reports, do not require a set schedule for Clinical Evaluation Report updates but do require manufacturers to have their own processes in place for when and how the Clinical Evaluation Report will be updated.

Read more about Clinical Evaluation report >>

Clinical Evaluation Plan >>

Buy read to use customizable procedures and templates >>

POST MARKET ACTIVITIES [ PMS + PMCF + PSUR ]

MDR Post Market Surveillance

MDR 2017/745, Chapter VII, Section I, states for each device, manufacturers shall plan, establish, document, implement, maintain and update a post market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device manufactured in article 83, 84, 85 & 86.

Article 61, annex XIV states all manufactures shall conduct a Clinical Evaluation in accordance with the requirements set out in Article.

Post Market Survelliance >>

Post Market Clinical Follow Up >>

Periodic Safety Update Report >>

PMS + PMCF + PSUR Writing Service & Consultation Fees >>

CER  Frequently Asked Questions
Clinical Evaluation Procedure
Clinical Evaluation Plan
Clinical Evaluation Report Sample
CER GAP Analysis
CER Procedure & Plan
CER Brochure
Clinical Evaluation Article

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