Precision ADM Inc reported on Thursday the receipt of the ISO 13485:2016 Quality Management System certification for its first Canadian metal Additive and Subtractive manufacturing services company.
This ISO 13485:2016 industry standard reportedly represents the comprehensive set of requirements for the design and manufacture of medical devices.
Achieving ISO 13485 Registration and Certification allows the company to manufacture medical devices, including Orthopaedic Implants, using the latest digital manufacturing technologies that can lower production costs by reducing waste and decreasing time to market by simplifying - or eliminating - tooling and equipment.
The Additive Manufacturing makes it possible to produce custom, patient-specific designs and devices with complex geometries, with potential lower cost than traditional manufacturing methods. The company is currently targeting additively manufactured medical devices produced in Titanium, Cobalt-Chrome and stainless-steel alloys.
Headquartered in Winnipeg, Manitoba, Canada, Precision ADM Inc is an engineering and manufacturing solutions provider that uses Additive Manufacturing, also known as 3D Printing, as a core technology, complimented by multi-axis machining to manufacture high value components and devices for the medical and industrial sectors.
Saluda Medical secures CE certification for EVA Sensing Technology in Europe
Antin to acquire clinical trial equipment provider Emsere
Hyphens Pharma licenses Cerapro skin cream to Louis Widmer for six European markets
Profusa signs French distributor to expand Lumee Oxygen rollout in Europe
Sensiva Health names new chief operating officer
BrioHealth Solutions enrols 100th participant in BrioVAD System trial
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
BioCryst wins FDA approval for oral HAE prophylaxis in young children
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
Clinical Laserthermia Systems applies for CE marking of ClearPoint Prism neuro laser system