Chandan Suresh

FAQ About Chandan Suresh

• What is Chandan Suresh's address?

  Chandan Suresh is located at
  Mysore, Mysore, India

• What is Chandan Suresh's job title?

  Chandan Suresh is a
  A clinical and regulatory professional with keen passion on clinical development and marketing authorisation of healthcare products. • Planning and execution of clinical evaluation as per MEDDEV 2.7.1 Rev 04 and MDCG 2020-6 for class IIb and Class III devices. • Planning and conduct of clinical investigations (trials) as per ISO 14155 and MEDDEV 2.12/2 Rev 2. • Interpretation of different country’s clinical evaluation regulations and guidelines. • Planning for the clinical validation of NIBP module as per ISO 81060-2 and pulse oximeter as per ISO 80601-2-61. • Preparation of documents related to clinical evaluation of medical devices which included clinical evaluation plan, clinical evaluation reports, clinical investigation plan, clinical investigation reports, clinical literature evaluation plan, clinical literature evaluation report, post market clinical follow up plan, post market clinical follow up reports, summary of safety and clinical performance, post market surveillance plan and periodic safety update reports. • Preparation of documents related to clinical investigation of medical devices which included protocols, case report forms, investigator brochure, informed consent forms, assent forms, statistical analysis plan, interim reports and final study reports. • Worked on development of process for interfacing of clinical evaluation, risk management and post market surveillance. • Development of workflow and procedure for the execution of clinical investigations. • Collaborated with biostatistician, investigators, onsite research teams, ethics committee and vendors. • Responsible for ethics committee dossier compilation, study start up, study related trainings, onsite monitoring, supply chain, coordination, vendor, budget and cross functional team management. • Troubleshooting of onsite issues and management of product bugs identified in clinical studies. • Usability validation as per IEC 62366-1, IEC TR 62366-2 and USFDA guidance. • Supported for investigator initiated clinical studies in the area of endodontics and physiology. Stryker

• What industry does Chandan Suresh currently work in?

  Chandan Suresh currently works in the
  Stryker

• What is Chandan Suresh's area of expertise?

  Chandan Suresh specializes in
  A clinical and regulatory professional with keen passion on clinical development and marketing authorisation of healthcare products. • Planning and execution of clinical evaluation as per MEDDEV 2.7.1 Rev 04 and MDCG 2020-6 for class IIb and Class III devices. • Planning and conduct of clinical investigations (trials) as per ISO 14155 and MEDDEV 2.12/2 Rev 2. • Interpretation of different country’s clinical evaluation regulations and guidelines. • Planning for the clinical validation of NIBP module as per ISO 81060-2 and pulse oximeter as per ISO 80601-2-61. • Preparation of documents related to clinical evaluation of medical devices which included clinical evaluation plan, clinical evaluation reports, clinical investigation plan, clinical investigation reports, clinical literature evaluation plan, clinical literature evaluation report, post market clinical follow up plan, post market clinical follow up reports, summary of safety and clinical performance, post market surveillance plan and periodic safety update reports. • Preparation of documents related to clinical investigation of medical devices which included protocols, case report forms, investigator brochure, informed consent forms, assent forms, statistical analysis plan, interim reports and final study reports. • Worked on development of process for interfacing of clinical evaluation, risk management and post market surveillance. • Development of workflow and procedure for the execution of clinical investigations. • Collaborated with biostatistician, investigators, onsite research teams, ethics committee and vendors. • Responsible for ethics committee dossier compilation, study start up, study related trainings, onsite monitoring, supply chain, coordination, vendor, budget and cross functional team management. • Troubleshooting of onsite issues and management of product bugs identified in clinical studies. • Usability validation as per IEC 62366-1, IEC TR 62366-2 and USFDA guidance. • Supported for investigator initiated clinical studies in the area of endodontics and physiology.

• Which languages does Chandan Suresh speak? 

  Chandan Suresh speaks the following languages:
  No languages available.

• Which industries has Chandan Suresh previously worked in?   

  Chandan Suresh has prior experience in the following industries:
  Skanray Technologies , Skanray Technologies , Alcon , Alcon

• What is Chandan Suresh’s work experience?  

  Chandan Suresh has the following professional experience:
  Stryker , Skanray Technologies , Skanray Technologies , Alcon , Alcon .

• How can I find Chandan Suresh on LinkedIn?  

  You can view Chandan Suresh’s
  LinkedIn profile at LinkedIn URL.

• What are Chandan Suresh’s work email addresses?  

  Chandan Suresh’s work email addresses are
  [email protected] .

• What company does Chandan Suresh work for?  

  Chandan Suresh works at
  Stryker