MAC Surgical Pty Ltd Have Achieved Compliance to ISO 13485

14 Dec 09

"I’m proud to announce that MAC Surgical Pty Ltd has achieved compliance to ISO 13485:2003 for Medical Devices  BSI Certificate .No.  MD 555324 (Quality Management Systems - Requirements for Regulatory purposes)", said Bob Lye, Managing Director.
 
"MAC Surgical is now accredited to 'Design,  manufacture, service and repair medical devices'  in accordance with that standard. This accreditation follows 12 months of intense effort to establish a quality system that enables us to offer this new standard of service excellence."  

"The introduction of the Therapeutic Goods Act 2002 (with mandatory compliance in 2007), has resulted in tighter regulation of medical devices with an emphasis on accredited quality management systems.  Quality accreditation provides many benefits including full traceability of materials, validated processes and a controlled environment.  MAC Surgical operates under approved processes that ensure all work complies with the Therapeutic Goods (Medical Devices) Regulations 2002. This provides our customers with peace of mind that their goods are handled in accordance with current government regulations."

New Standards, New Equipment.

"To further enhance our compliance with these new standards, MAC Surgical has recently made substantial equipment investments to expand the range of services offered by our manufacturing, service and repair department. This enables the in-house provision of laser marking, passivation, and wire-cutting.  These additions complement the existing offerings of CNC (computer numeric control) Turning, CNC Milling, Spark Eroding, and stainless steel TIG welding."

"MAC Surgical welcomes the opportunity to build on our business relationship with you.  We would appreciate an opportunity to meet with you in person to discuss in greater detail our new service offerings."

Bob Lye
Managing Director – MAC Surgical

Click here to view MAC Surgical's ManufactureLink supplier showroom and to contact them.

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