Testing and Compliance
Latest Testing and Compliance Feature
Copying, counterfeiting and lack of property rights have made the West wary of working with Chinese manufacturers. However, all that could change as legislation becomes more strict and countries work together. Meanwhile, the US and EU are seeing regulatory changes of their own, explains Thomas C Novelli of the MDMA.
What Lies Beneath the Mask?
The H1N1 or swine flu virus is spreading further across the globe on a daily basis.
The H1N1 or swine flu virus is spreading further across the globe on a daily basis.
A Costly Global Challenge
Can medical innovation fight back against the pressures of funding and patent protection?
Can medical innovation fight back against the pressures of funding and patent protection?
Testing Times
As regulatory processes increase in complexity, manufacturers and authorities must work to ensure standards are met.
As regulatory processes increase in complexity, manufacturers and authorities must work to ensure standards are met.
Shared Responsibility
When a new medical device is launched, the manufacturer's responsibilities have only just begun.
When a new medical device is launched, the manufacturer's responsibilities have only just begun.
Compared Care
Healthcare expenditure is continuing to rise as more treatment options become available.
Healthcare expenditure is continuing to rise as more treatment options become available.
Effective Directives
John Wilkinson of Eucomed looks at the results of recent changes to medical devices directives.
John Wilkinson of Eucomed looks at the results of recent changes to medical devices directives.
Risky Business: Quality Control and Fines
Why are many medical companies still risking fines with oversights and poor judgement in manufacturing processes?
Why are many medical companies still risking fines with oversights and poor judgement in manufacturing processes?
Regulation and Risk: New Device Directives
New European rules are aimed at removing confusion over clinical trials for medical devices.
New European rules are aimed at removing confusion over clinical trials for medical devices.
The Risks of Reuse
Despite their name, single-use devices are often reprocessed or reused, causing much concern for patient welfare.
Despite their name, single-use devices are often reprocessed or reused, causing much concern for patient welfare.
Report to Reduce Harm
Safety comes first: vigilance guidelines must be followed by all manufacturers to reduce the risk of patient incidents.
Safety comes first: vigilance guidelines must be followed by all manufacturers to reduce the risk of patient incidents.
Under the Influence?
Freebies from drug and device companies may have a biased effect on which treatments physicians choose to prescribe.
Freebies from drug and device companies may have a biased effect on which treatments physicians choose to prescribe.
Phase out the Fakes
Medical counterfeiting globally is rife, with only a fifth of countries having strict regulations to prevent forgery.
Medical counterfeiting globally is rife, with only a fifth of countries having strict regulations to prevent forgery.
12 Steps to Success
Karen Greene looks at how medical device packaging companies can cut down on their product delivery times.
Karen Greene looks at how medical device packaging companies can cut down on their product delivery times.
Regulations Rewritten
Investment in medical device development in the US is growing rapidly, but medtech companies face regulatory pressures.
Investment in medical device development in the US is growing rapidly, but medtech companies face regulatory pressures.
The Race for ROHS Compliance
The EU’s hazardous substances directive, RoHS, is already causing confusion among medical device manufacturers.
The EU’s hazardous substances directive, RoHS, is already causing confusion among medical device manufacturers.
Identification Improves Device Use
Medical devices need to be identified and classified to prevent the threat of counterfeiting and patient safety hazards.
Medical devices need to be identified and classified to prevent the threat of counterfeiting and patient safety hazards.
Microscopy as a Selling Tool
Dr Steven L Goodman of 10H Technology discusses how light microscopy can be used in developing medical devices.
Dr Steven L Goodman of 10H Technology discusses how light microscopy can be used in developing medical devices.
USA Playing Catch Up
While most of the developed world uses the ICD-10 classification system, the USA continues to lag behind.
While most of the developed world uses the ICD-10 classification system, the USA continues to lag behind.
hTEPs: The Regulatory Challenge
Richard Moore of Eucomed argues for the risk-based approach to regulation used in the medical device field.
Richard Moore of Eucomed argues for the risk-based approach to regulation used in the medical device field.
Medical Device Test Strategies
Medical device manufacturers must devise and implement an effective production testing strategy.
Medical device manufacturers must devise and implement an effective production testing strategy.
Device Sector Thrives on Fair Market Access
Mark Leahey identifies some of the obstacles to a free market in medical devices.
Mark Leahey identifies some of the obstacles to a free market in medical devices.
Words and Deeds
The approvals process should be integral to a product's development strategy.
The approvals process should be integral to a product's development strategy.
Electronic Record Keeping: Making Sense of Regulation and Compliance
Unsure of the current electronic record keeping regulations?
Unsure of the current electronic record keeping regulations?
