Hariharan M Email & Phone Number

Chennai, Tamil Nadu, India

Working on submissions for a wide range of Endoscopy Accessories for East Asian Countries Working on DMF and technical documents for the CDSCO submissionWorking on MDD-MDR Transition

Bengaluru, Karnataka, India

Overhauling the project deliverables Internal reviews of technical documents and internal technical repository documentsAssist in the preparation of technical presentations/ meetings with managersCoordination with internal stakeholders to ensure the quality of deliverables

Bengaluru, Karnataka, India

Regulatory submission will also include Preparation of requirement checklists and all the associated evidences right from Device specification, Requirements to Risk analysis, Verification and Validation.Preparation of IFU’s, Operation Notes from third partyand verifying it for timely release for new updates.Expertise in Regulatory Standards of Country wiseRequirements,The Registrations has also demanded type testing in few specific markets were as many accepted the Global standards of IEC 60601 -1, IEC 60601-2-37, IEC 60601-1-6.The other standards, type testing, in which I have beeninvolved are FCC ISED ETSIReviewed and edited FU, labels, risk assessmentand biocompatibility assessment files for clarity,accuracy and compliance with Europeanregulations as well as ISO 13485, ISO 14971standard requirements.Review of IEC 62304 and 60601-1 standardscompliance requirements.Review of regulatory documents includingTechnical Files, Declarations of Conformity forproduct registrationReview of biocompatibility and safety assessment, review of medical device software compliance requirements.Been a part of creating Share point where all thecommon Documents like EU FSC, CG can be sharedquickly and easily.Assisting with Risk Management activities including UFMEA and DFMEA development.

Bengaluru, Karnataka, India

Have taken to be a part of the Critical breakdown calls independently from ICU to OTManaged Operation Theater breakdown calls effectively. Overall Insight of all Surgical procedures in OTIdentify elements and requirements for improvement of maintenance posture for medical devicesAssisted in various surgical procedures during unexpected critical equipment breakdownLocale engineered a High flow therapy machine which was implemented in ICU’sManaged with in-house clinical team and saved upto 10 million INR. Regular Clinical training on medical applications and equipment are given to clinicians and staffUpdating theoretical knowledge on legislations governing medical products. Reports and documentation are filed with respect to the changes that occur in the equipment , since the installationOrganised and coordinated application procedures of medical devices, which is bound to be difficult to keep it upright