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.

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..

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 &.
• 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.
• 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.

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

B.Pharm, Pharmacy, 64%

Activities and Societies: Football and Basketball player