La-med Healthcare Pvt. Ltd.
“Quality is never an accident. It always the result of high intention, sincere efforts, intelligent direction and skillful execution”

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

La-med meets or exceeds all of the medical industry quality standards. Development, manufacturing, warehousing, documentation and traceability meet Quality Systems Regulations.   

La-med 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
Quality Policy
We, at La-med Healthcare Pvt. Ltd. are committed to manufacture & supply of Medical Devices...
To deliver Quality Products with continual improvement.
To maintain & comply with the statuary & regulatory requirements.
To comply the outcome of implemented qaulity management system including reort of risk assessment & clinical evaluation of the product time to time.
To review the policy from time to time for continuing suitability to the organization.
Business Growth.
Compliance of requirement, i.e., Statuary & Regulatory.
Meeting customer's requirements.
Minimize Rejection & Wastages.
Timely delivery of goods.
Inventory Control.
To maintain the brand value.
General information
Compliance with G.M.P. Regulation.
At La-med, 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 Quality Assurance and regulatory system comply with ISO 13485:2016 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 13485:2016 and our CE mark certificates
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