ISO 9001-2015
ISO 9001-2015 Certificate
The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based.
Medisafe International (MSI) is ISO 9001-2015 Quality Management System (QMS) Certified Company.
ISO 13485-2016
ISO 13485-2016 Certificate
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
Medisafe International (MSI) is ISO 13485-2016 Breakthrough Management Quality Registrar (BMQR) Certified Company.
WHO-GMP Complaince
WHO-GMP Complaince
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Medisafe International (MSI) is WHO-GMP World Health Organisatio-Good Manufacturing Practices Compliance Company.
CE Compliance
CE Compliance
CE marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.
Medisafe International (MSI) is CE (Conformité Européene) Compliance Company.
CE Compliance
CDSCO-MD5 Certificate
CDSCO approval is mandatory for medical devices in India. Medical device manufacturers must apply to the CDSCO for regulatory approval (CDSCO Certification). This application should include information about the medical device, its uses, technical specifications, manufacturing processes and other relevant details.
A-Medical devices.
This includes a wide range of devices used for diagnostic, therapeutic, or monitoring purposes, such as blood pressure monitors, heart monitors, ventilators, and surgical instruments.
B-Diagnostic Products
Diagnostic tools, laboratory equipment, and test kits for various medical tests may also fall under CDSCO registration.
D-Consumables
Medical consumables such as disposable syringes, catheters, bandages and sterile products may be subject to CDSCO certification.
E-Implants
Medical implants such as artificial joints, pacemakers, and other implantable devices may also fall under CDSCO registration.
We Medisafe International have CDSCO-MD5 Registration Certificate for our products.
Quality Policy
We believe in providing quality of highest level. The fact that we are in a business which is
directly linked to the health and wellbeing of the people makes us more responsible company, and
no matter what, no compromises are made. No doubt, life is precious.
Not only our products conform to ISO 9001:2015, ISO 13485:2016,WHO-GMP & CE standards, but
we also constantly exceed international quality norms. We boast of the most modern factories
which have the state of the art manufacturing facilities. Also, rigorous quality assurance
resources ensure stricter quality control.
Medisafe International Services
Silicone Resuscitator
Silicone resuscitator,Ambu Type Bag for Adult, Child, Infant in 3 colours Blue, Green, White with 40 times autoclable at 134* C.
Anesthesia Accessories
Guedel Airways, Nasopharyngeal Airways, Silicone Head Harness, Teeth Opener, Silicone Ring Pessary.
LMA & Laryngoscope
PVC LMA, Silicone LMA, Laryngoscope Matt Finish for Adult & Child, Fibre Optic Laryngoscope for Adult & Child.
Disposable Mask
Air Cushion, Oxygen Mask with reservoir Bag, Nebulizer Mask, Venturi Mask with Single/Six Diluters
CPAP/BIPAP Mask
CPAP/BIPAP Mask, NIV Mask,Nasal Mask, Full Face Mask, NIV Mask with Brnoscopy Port,CPAP Circuit,Head Strap.
Manual Suction Unit
Vacuume Extractor Bird Type & malmstrom Type, Silicone Cup (Ventouse) Plane & with Release Volve.