Certifications


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ISO 13485:2016

ISO 13485:2016 is a company level certification based on a standard developed and published by the International Organization for Standardization (ISO) titled "Medical Devices-Quality Management Systems Requirements for Regulatory Purposes". The standard includes portions of ISO 9001 but excludes some clauses that are not appropriate for the regulatory requirements. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

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ISO 9001:2015

For over a decade, Innovative Gloves has earned recognition from ISO for quality management and providing excellent distribution, manufacturing, R&D and customer services. ISO is the world's largest developer and publisher of International Standards including ISO 9001:2015, which applies to the systems and processes that create and control the products and services an organization supplies. Organizations must pass a rigorous quality management system audit to confirm ISO 9001:2015 compliance.

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U.S. FOOD AND DRUG ADMINISTRATION (FDA)

Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations. Medical gloves are one part of an infection-control strategy. Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). These gloves are regulated by the FDA. FDA reviews these devices to ensure that performance criteria such as leak resistance, tear resistance and biocompatibility are met.

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CONFORMITÉ EUROPÉENNE (CE)

A key consideration for all types of personal protective equipment (PPE) is to ensure that the product has been appropriately CE marked as this is a mandatory requirement for PPE products entering the European market. This not only covers evaluation of initial examples, but also bulk production. The CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer.

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THERAPEUTIC GOODS ADMINISTRATION (TGA)

The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. TGA administers the Therapeutic Goods Act 1989, applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficiency (performance), when necessary. The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medical devices. The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.

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CANADIAN MEDICAL DEVICES REGULATIONS (CMDCAS)

The application process for a Class II, III or IV Medical Device License requires manufacturers to demonstrate that their products are safe and effective, and that they meet applicable standards. To verify compliance with the quality system requirements, companies applying for a Medical Device License must submit evidence of certification to the requirements of ISO 13485. To sell a medical device in Canada, manufacturers must meet the regulatory requirements as defined in the Medical Devices Regulations. Manufacturers of Class II, III, and IV medical devices must obtain a licence before selling them in Canada.