Testing and Compliance
Compared CareHealthcare expenditure is continuing to rise as more treatment options become available.
Effective DirectivesJohn Wilkinson of Eucomed looks at the results of recent changes to medical devices directives.
Shared ResponsibilityWhen a new medical device is launched, the manufacturer's responsibilities have only just begun.
Risky Business: Quality Control and Fines Why are many medical companies still risking fines with oversights and poor judgement in manufacturing processes?
Regulation and Risk: New Device DirectivesNew European rules are aimed at removing confusion over clinical trials for medical devices.
Report to Reduce HarmSafety comes first: vigilance guidelines must be followed by all manufacturers to reduce the risk of patient incidents.
The Risks of ReuseDespite their name, single-use devices are often reprocessed or reused, causing much concern for patient welfare.
Phase out the FakesMedical counterfeiting globally is rife, with only a fifth of countries having strict regulations to prevent forgery.
Under the Influence?Freebies from drug and device companies may have a biased effect on which treatments physicians choose to prescribe.
12 Steps to SuccessKaren Greene looks at how medical device packaging companies can cut down on their product delivery times.
Identification Improves Device UseMedical devices need to be identified and classified to prevent the threat of counterfeiting and patient safety hazards.
Regulations RewrittenInvestment in medical device development in the US is growing rapidly, but medtech companies face regulatory pressures.
The Race for ROHS ComplianceThe EU’s hazardous substances directive, RoHS, is already causing confusion among medical device manufacturers.
Microscopy as a Selling ToolDr Steven L Goodman of 10H Technology discusses how light microscopy can be used in developing medical devices.
USA Playing Catch UpWhile most of the developed world uses the ICD-10 classification system, the USA continues to lag behind.
Device Sector Thrives on Fair Market AccessMark Leahey identifies some of the obstacles to a free market in medical devices.
hTEPs: The Regulatory ChallengeRichard Moore of Eucomed argues for the risk-based approach to regulation used in the medical device field.
Medical Device Test StrategiesMedical device manufacturers must devise and implement an effective production testing strategy.
Words and DeedsThe approvals process should be integral to a product's development strategy.
Electronic Record Keeping: Making Sense of Regulation and ComplianceUnsure of the current electronic record keeping regulations?
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