Training Sessions

Conducted training sessions in Surgical Association regarding new EU Regulatory requirements (MDR) and got good feedback from the participants including various manufacturers.

Software Validation

Software validation terms most of the time create complications for proper understanding the topic. GTI has thoroughly made understanding to the users and made available formats are the part of validation protocols.

Cleanroom Development

Developed cleanroom as per ISO 14644-1 and organizational capacity for productivity analysis per month the space allocation suggested and monitoring strategies for environmental controls, employee’s behavior and cleaning agents for controlling microbial load on the devices.

Process Validation

Carried out process validations covering design, installation, operational and performance qualification for most critical and complicated processes.

Vigilance Cases

Handled lot of vigilance cases including death and serious injuries to patients and users’ cases closures as per the vigilance protocols by covering the latest requirements of the manufacturer investigation reports formats.

Biological Assessment

Performed biological assessment from material to packaging of the medical devices by following the ISO 10993 series relevant to the duration of the medical devices including process residual assessment in the term of organic carbon contents conducted that is the part of the chemical characterization.

Product performance and safety assessment

Product performance and safety assessment as per harmonized standards particular to the product and processes established also help to identify the relevant risks and controls add up into product design phases.

Electrical Testing as per IEC Standards

Initiated electrical testing as per IEC standards series related to the active medical devices, IEC 60601-2-2. IEC 60601-1-2, IEC 60601-1 and compliance on IEC 60601-1-6. Formatting for reports by following lab qualification for the acceptance of product safety results.

Medical device files development

Developed medical device for different types of products (Reusable Surgical Instruments, Diagnostic Instruments, Electrosurgical Instruments, Ophthalmology Instruments, X-ray films and Beauty care Instruments)

Clinical Simulation

Initiated clinical simulation testing within organization’s premises and addressed customer complaints by drafting inspection methods.

Validation as per ISO 11135:2007/2014

Worked for process validation for estimated 50 products (Made of polymers, rubbers and stainless steel) processed in ETO sterilization validation protocols by carrying out ETO cycles setting out variable parameters for the evaluation of the products and material performance.

Validation as per ISO 14937:2009

Worked for process validation as per ISO 14937 standard guidelines and got approval from Notified Body in first attempt without any major non-conformance.

Implementation of quality management system in accordance with ISO 13485:1996 and FDA approval

Established quality management system for our client in accordance with ISO 13485:1996 and got approval from FDA and certification body.

Implementation of quality management system in accordance with ISO 13485:2003 and Directive 93/42 EEC

Developed quality management system in accordance with ISO 13485:2003 and got success for the development, implementation and certification of the new standard within Pakistan along with Directive 93/42 EEC.