MPC Data is a world class software integration company providing quality embedded software design services and products. Achieving ISO13485 certification offers existing and new customers additional assurance that MPC Data can play a pivotal role in some of the most critical areas of the design process and assist with bringing high quality products to market, faster and with reduced risk.
So what is ISO13485 exactly? ISO 13485:2003 defines requirements for a quality management system (QMS) used by companies designing and manufacturing medical devices and associated services. The primary goal of the standard is to promote harmonization of regulatory requirements for medical device manufacturers.
The standard contains specifics for “Risk management” which is performed throughout the product development and product realisation process. An ISO13485 management system can be thought of as a framework on which to build compliance to various regulatory and customer requirements. The heavy focus on risk assessment and traceability (documentation)
MPC Data has been continually improving its ISO9001:2008 quality procedures with a view to gaining ISO13485 compliance in the last few years. Although not mandated within ISO13485, adherence to EN62304 is highly desirable and greatly simplifies regulatory compliance. EN62304 is a software development life-cycle process for medical device software and MPC Data’s Software Development Process has been successfully audited to meet EN62304.
Stephen Bashford, MPC Data’s Quality Manager, recently presented on the subject of "Using ISO 13485 to develop medical software for FDA & European Certification"
Stephen states “The production of high quality software meeting customer requirements has been the top of the agenda throughout our company’s existence – our focus has been on production ready, quality products from day one. I personally take great pride in achieving ISO13485 certification which means we can offer our customers further assurance on the quality, reliability and regulatory compliance of our software.”
MPC Data offers software services for medical product development:
• Hazard analysis and risk assessment
• Requirements capture
• Processor & operating system recommendations
• Project management
• Software design and development
• Software verification and validation
For Hardware MPC Data has ISO13485 accredited partners to undertake:
• Hardware design
• Industrial, ergonomic and user interface design
For system risk management MPC Data works closely with Ebeni – a company focussed on Safety and Risk Engineering services for high integrity safety and mission critical industries, their geographic proximity, experience and independence is highly valued by customers.
MPC Data has an excellent track record in medical and healthcare systems including:
• Infusion pumps
• Fully automated PCR (Polymerase Chain Reaction) diagnostic mini laboratory for testing of infectious diseases at the point of care
• Intelligent docking station and network interface to HIS (Hospital Information System)
• Foetal heart monitors
• Mobile diabetes monitors
Phil Buckley, MPC Data’s Deputy Managing Director, states “MPC data has an excellent reputation in the safety critical and medical product development fields and is continually investing in quality and reliable software practices. ISO13485 accreditation makes it easier for our customers to outsource to MPC Data by establishing a recognisable standard and removing the obligation on them to audit our quality procedures. It has always been our goal to bolster our client's software development capability by providing the specialist software development expertise that may not be available in-house allowing the client's team to focus their domain knowledge on differentiating their product to keep ahead of their competitors.”
Continuous innovation and high demand within Medical and Healthcare electronics is leading to high growth opportunities for Medical Equipment designers, and very often the in-house medical expertise does not include embedded software which is required in many of today's patient care and user friendly devices. MPC Data with it's history in the embedded software development field and considerable expertise in QNX, Linux and WinCE offers a viable alternative to increase product reliability, quality and reduce development times and risk.
Contact MPC Data today to discuss how they can help you with your Medical Equipment design.
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MPC Data is a World Class Engineering Services provider for Embedded and Real time product developments based on QNX, Embedded Linux, Windows Embedded. A key partner of choice for major OEMs and start ups and focused on the following markets:
• Medical, Healthcare & Safety Critical Products
• Automotive Infotainment & Transportation
• Industrial Automation
• Video Security & Access Control
• Broad Market: Training, Board Support Packages & Consultancy