Celegence partners with Medical Device and IVD manufacturers at various product lifecycle stages to draft compliant Technical Files (EU) / Device Master Records (US). Depending on the specific region’s regulatory status, Celegence can either draft, remediate, or update a manufacturer’s Technical File / Device Master Record for a regulatory submission. We help customers gain market access/approval compliant with the EU’s MDR 2017/745 and or the US FDA 21 CFR 820 for either region-established regulatory pathway which includes the EU’s CE Marking conformity assessment or the US (Premarket Notification (510(k)), De Novo Classification Request, Premarket Approval (PMA), and Humanitarian Use Exemption (HDE) submission.
Quality Management Systems (QMS) equally play a key role in the certification process of a medical device irrespective of the targeted region. Celegence also partners with medical device manufacturers to implement quality management systems complaints to either the ISO 13485 and or the US 21 CFR 820 Quality System Regulation (QSR)
Post-Market Surveillance Services (PMS)
Clinical Evaluation Report (CER)
Celegence assists medical device and IVD manufacturers with the creation of the following components of the technical file or Device Master Record:
Technical Files and DMRs can be structured in many ways, a typical folder structure adopted by Celegence is as below.
Device Description
Information Supplied by the Manufacturer
Design and Manufacturing Information
GSPRs
Risk Management
Verification and Validation
Clinical Evaluation
PMS
Declaration of Conformity
Team Lead, Medical Device Services
Prasad Ravichandran is an experienced regulatory affairs professional with expertise in medical and in-vitro diagnostic devices. An IRCA-certified lead auditor for ISO 13485:2016, he has over 10 years of experience in regulatory compliance, quality management, and clinical trial submissions.
At Celegence, he leads regulatory compliance initiatives, ensuring EU MDR and IVDR adherence while managing technical documentation, risk assessments, and post-market surveillance. His strategic approach and in-depth regulatory knowledge support seamless compliance for medical device manufacturers.
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Senior Manager, Medical Device Services
Manicka Sundaram R is a seasoned regulatory and compliance professional with over 14 years of experience, including a decade in the medical device industry. He specializes in design history file remediation, risk management, and compliance with global regulatory standards.
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25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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