One of the more important realizations that the COVID-19 pandemic has taught us, is that our reliance on international manufacturers responsible for supplying the critical PPE we require to safely operate our clinical establishments presents several critical risk factors associated to supply chain stability, price point volitility, ease of access and quality control compliance. These risk factors have direct negative impacts on the safety of our front line health care workers and general public as a whole.
Access to a domestic, cost effective, reliable PPE supply chain is paramount in our ability to respond to, and combat a public health crisis of any nature.
MediGuard Systems of Canada is a Health Canada licensed manufacturer and distributor of Class 1 Medical Devices. We are currently producing ASTM level 1, 2 and 3 surgical masks inside of our ISO-8 (class 100,000) cleanroom, with a surgical mask production department capable of producing, packaging and distributing 120,000,000 surgical masks every year to ASTM-2100-19 standards within a ISO-13485 compliant production facility.
With an "Ease of Access" mandate to Federal, Provincial and First Nations organizations and communities across Canada, MediGuard systems provides fast, compliant and cost-effective solutions to accessing Canadian made PPE while protecting the public and our front line health care workers.
Entering the clinical-grade PPE industry in Canada and around the world can be a costly and time consuming endeavor. Acquiring an appropriate facility, establishing a MDEL, SOP's Policies and procedures, construction of a clean room, regulatory compliance implementation, supply chain stability, Costly insurance policies, and several other barriers to entry prevent many individuals from effectively entering the industry with a sustainable model.
Many distributors have traditionally opted to outsource the production of their brands surgical masks to facilities that have been more often than not located over seas. However, the risks associated to international production can create an undesirable level of liability and risk in relation to quality assurance measures, product surveillance, supply chain contanuity, and financial risks associated to the pre payment and delivery of potentally non-compliant goods. And even IF a buyer implements risk mitigation stratigies that protect them financially, (Escrow, LOC's etc), should a large order arrive and be found to be non-compliant, the buyer is left without product to deliver to their clients. and none the less suffers financial impacts related to loss of profits.
Mediguard Systems of Canada has established a highly stable and dynamic raw materials supply chain that through contractual obligation secures our up-stream with our suppliers. Raw materials used in the production of Mediguard Surgical masks undergo 3rd party ASTM-F2100 testing conducted by a Health Canada approved labratory, and during our production process we utilize hourly In-House labratory testing for BFE, PFE, Fluid Resistance, and Diffrential Pressure to continualy valadate the performance of our products.
Production of every ASTM mask by Mediguard Systems is conducted inside our ISO-8, Class 100,000 clean room. Mediguard is one of only a small hand full of Canadian mask production facilities manufactuering in an ISO clean room.
Mediguard Systems offers "white Label" surgical mask production for clients of all sizes. MOQ's for white label services start at 10,000 Boxes (500,000 masks), and for larger ongoing orders we are able to offer ongoing scheduled production with a standing PO.
Mediguard offers short production lead times, Dropshipping service, competitive price points, and free packaging design that is always compliant for the products destination.
For product with international destinations, Mediguard Systems can produce and certify to EU standards EN14683: 2019, & ASTM F2100 for (USA/MEXICO), and custom performance certifications upon request.
Production testing of a 2+1 mask making line.
ASTM level 1, 2 and 3 Procedural and surgical masks. Produced In Barrie Ontario Canada in our ISO-8 Class 100,000 clean room
EU, CE and FDA Approved FFP level respirators specifically for the EU market.
Nitrile gloves available for production orders, EU, CE, FDA and Health canada authorised medical use.
Protect your staff and PT's with point-of-care rapid testing solutions for antigen and antibody rapid test protocols with results in 15 min or less.