Quality

“Quality is never an accident. It always the result of high intention, sincere efforts, intelligent direction and skillful execution”

La-med^TM is well aware of its responsibility as a supplier of devices and components to the leaders in the medical field.

La-med^TM meets or exceeds all of the medical industry quality standards. Development, manufacturing, warehousing, documentation and traceability meet Quality Systems Regulations. La-med^TM's Medical Quality Management System (MQMS) is certified as per ISO 9001:2000, ISO 13485:2003 & ISO 14971 risk management standards.

La-med^TM products have earned the prestigious C.E. Mark as per Medical Device Directive 93/42/EEC which indicates that the products conforms to all relevant essential requirements and other applicable provisions that have been imposed upon it by means of European directives, and that the product has been subject to the appropriate conformity assessment procedure(s). The essential requirements refer, among other things, to safety, public health and consumer protection.

We meticulously build quality throughout products at each step right from vendor development, raw material, in process Q.C. to finished process Q.C.
There is no compromise on the efficacy, stability and shelf life of our products. Quality is the watch word at La-med^TM.

We at Lakhani Medicare Pvt Ltd aim to ……..

• Strive for the highest level of customer satisfaction by fulfilling dynamic needs of our global customer and by delivering consistently high quality products with continual improvements.
• Provide a work environment and culture, which promotes initiatives, innovations and teamwork.
• Maintain quality management system as per ISO 9001-2000, ISO 13485:2003, W.H.O. GMP, statuary & regulatory requirements.

Compliance with G.M.P. Regulation.
At La-med^TM, Injection molding carried out in Class 100,000 clean room (according to ISO 14644 class 8) and all other manufacturing activities up to packing are performed in Class 10,000 clean room environment (according to ISO 14644 class 7). Production, warehousing, components, documentation and traceability is performed in full accordance with the Medical Quality System Standards (MQMS)

Compliance with ISO 9001 and ISO 13485 standards
La-med^TM Quality Assurance and regulatory system comply with ISO 9001:2000 and ISO 13485:2003 standards.

Biocompatibility Testing
All raw materials tested as per the requirements described in I.P. & USP for physicochemical testing. Manufactured products comply to the ISO 10993-1 requirements.

Quality Documents
Need our quality certificates for your files? Please download ISO 9001:2000/ ISO 13485:2003 and our CE mark certificates