· ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, Clause 2
· EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
· ISO 9000:2015 Quality Management Systems – fundamentals and vocabulary
· Indian Medical Device Rules 2017
· MDR (EU) 2017/745
We at Aegis Lifesciences Pvt. Ltd. are committed
To Design, Develop and Manufacture, medical devices for management of bleeding, conforming to International standards that ensure highest safety and claimed efficacy
To ensure delivering of quality products that meet all the requirements of customer and regulatory norms
To provide all the resources needed to implement an effective quality management system
To continue to conduct professional training at all levels to increase the knowledge and competency of employees
To make continual improvement at all stages of operations and strive to be the industry leader
To be benchmark in all areas of operation
Quality System Management (QSM)
· This Quality System Manual (QSM) is prepared to demonstrate the ability of Aegis Lifesciences Pvt. Ltd. (Hereinafter Aegis) for Design, Development, Manufacture, Distribution and Sales of Sterile Surgical Haemostatic Sponge, Absorbable Haemostats, Wound care and Haemostatic Dressings.
· The QSM is divided into eight sections modeled on the sectional organization of the ISO 13485:2016/EN ISO 13485:2016 and IMDR 2017 standard. Sections are further divided into several sub-sections representing main quality system processes. Each sub-section defines general policies and basic principles for the pertinent quality system process; summarizes responsibilities and methods; and references relevant operational procedures and other documents.
· QSM is to define and describe the quality system, to define authorities and responsibilities of the personnel involved in the operation of the system and to provide a general description of all processes comprising the quality system.
· QSM is to present the quality system to customers, suppliers, regulators and other external interested parties and to inform them what specific controls are implemented at Aegis to assure quality. It is also the apex manual to internally communicate members on the QMS.
· Under the scope QSM, following products are included in the category of haemostatic medical devices but not limited to;