In addition, ISD does send further Lab test on SKY GEL Ultrasound Transmission Gel show that the product free from microbial growth performed on [USP60 <microbial examination of non-sterile products – test for Burkholderia cepacia>]

In order to ensure the safety and quality of SKY GEL Ultrasound Transmission gel. We had conducted the Preservative effectiveness Test. View here : Preservative effectiveness Test on Burkholderia cepacia. During the course of 28 days preservative effectiveness test on Microbial study, samples of SKY GEL  was undergo single challenge test by laboratory to simulate the conditions in a SKY GEL Transmission Gel.

Samples under challenge conditions met the microbial examination of non-sterile products – test for Burkholderia cepacia criteria. As long as a bottle that has been opened is stored properly in room temperature and not contaminated during use, the gel is expected to maintain its original shelf life.

1b. QUALITY PROCEDURES

ISD always strive to ensure Quality of the products and stringent quality assurance procedures include the following:

• Environmental monitoring program monthly tests several areas of the manufacturing and production areas for microbial contamination, including manufacturing and packaging equipment;
• Sanitizing manufacturing machineries and production areas daily;
• Microbial testing is performed monthly on the process water used to make all SKY GEL products and results have shown no presence of bacteria at all points of use;
• Sanitization of entire process water system is performed monthly;
• Continuous monitoring of water quality provides real-time indication of any system malfunction;
• Microbial testing is done on all SKY GEL products during the routine stability program every six months throughout the life of the product. There have been no indications of microbial growth;
• Pathogen testing on all production batches on SKY GEL demonstrates product is free from pathogens when manufactured.

1c. QUALITY ASSURANCE COMPLIANCES & COMPETENCY

We had identified on how to continuously improve our process on medical device quality thru strict regulation compliances and training on staffs:-

1. Quality assurance through Regulations & Audit
   
   As healthcare companies are becoming more inclined to value-based patient care, regulatory bodies have tightened the compliance requirements to increase transparency and ensure medical device quality and efficacy. With stricter norms and greater emphasis being given to patient safety, medical device manufacturers must establish processes to achieve compliance. ISD had obtained ISO13485 certification audited by TUV, Rhineland LGA Products, GMBH certification body and CE certification by Medical Device Safety Service GmbH. We also obtained approval from Malaysia Medical Device Authorities (MDA) and Good Manufacturing Practice Certificate (GMP) on all SKY GEL  products.

   QA Compliances > view here

2. Creating culture of quality and staff competency in the organization

   Quality begins with every employee and includes every process and procedure ranging from development to delivery. This involves implementing robust quality standard processes across the business. By improving quality across operations and establishing a comprehensive control mechanism, medical device manufacturers can cultivate a culture of quality. ISD provide training to all staffs enable them to equip with the ISO 13485 and ISO 14971:2019 Risk Management
   for Medical Device knowledge.