Medical Device

Pharma IT has an experienced team of consultants ready to assist you with services in all areas of Quality, Compliance and documentation within the Medical Devices industry.

Pharma IT provides services within the whole range of activities that is needed to implement and run a compliant QMS. Below are selected examples of services:

  • Process mapping, design and documentation
  • Creation of procedures, forms and policies
  • Operational compliance
  • Supplier Quality Management
  • Design Control
  • Rootcause analysis
  • Risk Management

Working with a strong QMS means, that your company is in control of the activities. It also means, that the company documents the actions and decisions performed – in accordance with the QMS.

Pharma IT has experienced consultants, who has worked with all levels of QMS implementation for Medical Devices companies, and can therefore provide skilled roles that offers support, management and facilitation of QMS projects.

Meet the Medical Device team:

Senior Pharmacovigilance & Device Consultant
Sukhjit Gill

Senior Pharmacovigilance & Device Consultant holding 12 years of experience from several pharmaceutical companies and additionally 3 years of experience within the medical device industry. She has experience working with various pharmacovigilance development and post-market surveillance tasks such as DSUR and PSUR/PBRER writing, setting up AE/SAE flows for clinical trials as well as reconciliation and MedDRA coding, SOP writing, Pharmacovigilance training, Literature monitoring, ICSR case processing and reporting, Device vigilance complaint handling, evaluation of serious incidents, reporting of MIRs and communicating with Regulatory Authorities/Notified Body and execution of Recalls/FSCA and FSN. Has been part of implementing the new MDR regulation within device vigilance

Clinical Evaluation for Medical Devices in Europe, Medical Devices: Regulation and Life Cycle Management, MedDRA Safety Data Analysis and SMQs
Director, Medical Device
Per Andersen

IT Project Manager/Architect with 20+ years of experience within pharmaceutical and medical device industry. Experience with infrastructure, Complex IT applications, ERP-Systems, BPM&N, WebServices, medical devices and Software as medical device software

Jira foundationals - Agile Development, Atlassian; Jama Foundationals, Requirements, Risk and Test Management; SAFé Agile / Scrum
Senior Pharma Consultant
Bettina Kok

Bettina Kok holds more than 15 years’ experience in the medical device industry working with a broad selection of projects in QMS, IT QMS, QA, Pharma IT projects and GDPR. Bettina holds in total 17 years’ experience working under various standards and directives with compliance and documentation, in highly regulated industries. Experience as a Compliance Manager, RA Consultant, Compliance Architect, Vigilance and Complaint Specialist and Track Lead (URS) on IT projects. Hands-on experience with IT and QMS documentation, process mapping, design and implementation of quality processes, to improve and secure compliance requirements.

Bettina has several years of experience with QMS systems preferred in medical device/pharma, ISO 13485 and ISO9001 compliant businesses. Such systems are for example: HIQMS, DOORS, ENOVIA, Track-Wise, Sharepoint, Improve, Veeva and Lotus Notes.

Risk Management, Document Management, Quality Management, Auditor, MDD 93/42 Compliance, EU GDPR, Data Protection Impact Assessment (ISO/IEC29134), Information Privacy Manager (IAPP)