The European Commission, Parliament, and Council recently suggested changes to the regulation of Medical Devices and In Vitro Diagnostics (IVD). Medical device companies in Europe are paying attention. Nearly a third said they are keeping a close eye on the proposal. A much smaller percentage of North American and Asian respondents are doing the same.
Entering such a rich market, irrespective of company origin, requires all manufacturers to stay informed and prepared.
Consequences of negligence
Most companies do not have the huge resources required to weather the fallout of recalls. When they fail to meet the European ISO quality system standards, they put the company at risk. Halted production and shipments means no revenue. Most businesses can’t sustain themselves during a long recall and recovery period.
This risk pushes companies globally to stay knowledgeable about ISO – in particular ISO 13485.
Why you should understand ISO 13485
The ISO 13485 standard gives specific requirements in a quality management system for medical device manufactures. Companies need to prove they can manufacture devices or provide related services that meet customer needs and pass regulatory requirements.
This encompasses one or all lifecycle stages:
Studying produce feasibility – market research.
Product conception and development and quality.
Production and/or distribution.
Installation, service, and end-of-life.
Europe is seen as one of the tougher markets to enter for medical device providers. Given the opportunities and strength of the market, it’s worthwhile.
Windchill Product Quality
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