Dennis Christopher Email & Phone Number

Tamil Nadu, India

Hyderabad, Telangana, India

 Registration/Renewal/Amendment in Health Canada, Singapore, Saudi Arabia (Tech file compilation and Essential Principle Checklist), Mexico (Technovigilance report), Indonesia, India, Australia, Brazil (InMetro Certification), Thailand & Malaysia. Technical documents - EUMDR 2017/745 (GSPR & STED) & SOPs (EUDAMED, Clinical investigation, PMCF, PMS, etc.,). 510(k) (eSTAR-Traditional, Special & Abbreviated), DeNovo, Pre-submission: Device description, Predicate device and Substantial equivalence, Declaration of Conformity, Software and cybersecurity, Electrical safety, Sterilization, Shelf life, Performance testing and Biocompatibility studies.  Establishment registration & Device listing (21 CFR 807), Medical Device Reporting/ Corrections and Removals - 21 CFR 803/806, Certificate to Foreign Government (CFG) & Device-led/Drug-led Combination products (USFDA). Consulting Services (SaMD, Health Canada & USFDA): Device Classification/Determination, Regulatory Intelligence & strategies on legislation, SOPs, Work Instruction, RFP, Blog articles and Effort hours estimation for Regulatory submissions.

Madurai, Tamil Nadu, India

510(K) Submission: Predicate device analysis, Product Applicability mapping, Pre-submission and Summary file preparation referring to USFDA Guidance document for medical devices with substantial equivalence rationale of novel devices from R & D.CDSCO activities: NPD - Regulatory pathway, Regulatory submissions - Form MD-16, MD-12, MD-22, MD-14, etc. Research on Regulatory strategies/pathway for commercialization of New Product Development- India & USA (Regulatory documents, Standards, Predicate device analysis (If any), Clinical Investigation (Clinical feasibility, Pilot or Pivotal, etc.,) and SaMD risk categorization based on IMDRF).

Chennai, Tamil Nadu, India

New Delhi

▪ Reviewer & Led 3 members team: Clarifications, NOC’s, Product Recalls and CAPA summary report, License Form: MD-12, MD-14, MD-16, MD-22 and MD-26 applications on regulatory and technical documents such as Plant & Device Master File, Risk Analysis, Biocompatibility, Clinical evaluation report and Post market surveillance report as per Medical Device Rules, 2017 (India).▪ Classification of new medical devices based on Intended use, Risk Class (Class A, B, C and D) and Regulatory status in GHTF Countries.▪ Coordinated and Recorded – Stakeholders/Association minutes of meeting on Surgical Dressings and Medical Equipment’s with regards to Medical Device Rules, 2017.

Bengaluru Area, India

▪ Lab-on-a-Chip: Microfluidic channels with osteoblast-like cells to comprehend mechanotransduction signalling pathways on fluid flow-induced shear stress and cellular metabolism in bone remodelling to treat bone disease conditions.▪ Scaffolds/Tissue Engineering: Application of rapid prototyping on 3D scaffolds fabrication with significant porosity to mimic bone morphology and evaluate its compressive modulus on physiological load for bone regeneration.

Master Of Technology (M.Tech.), Biomedical/Medical Engineering, 7.46 Cgpa

B.Pharm, Pharmacy, 64%

Activities and Societies: Football and Basketball player