Effective May 1, 2004 the EU grew by 10 Countries. Many in the Medical Device industry assumed that the three EU Medical Directives had been implemented in its entirety and became effective immediately. That is not the case.
For the full Medical Device report click HERE.
Machinery Manufacturers - For the full report click HERE.
INNOVATIVE SALES STRATEGIES USING CE-MARKING COMPLIANCE
Under the guidance of Mesterdene Ltd, we are developing
case studies that clearly define how manufacturers can
strategically use their compliant Technical Files to increase sales.
For a case study preview click here.
Canadian Inspection Strategy for Medical Device Companies
On June 17, 2003 Health Canada released their draft "Inspection Strategy for Medical Device Companies". Dates of Implementation Stage 1: November 2003, Stage 2: November 2004. All details can be found by
clicking here.
The Difference is $35.3 Million
In a recent court case settlement in Hennepin County, Minnesota, the jury learned that a safety device, similar to the light beams that prevent garage doors from closing on people, had been installed for 10 years in machines destined for Europe but not in those destined for the US market. This difference, considered a key piece of evidence, resulted in crushing of a worker's skull between a moving mechanical arm and a conveyor belt below it, on his third day on the job. The jury awarded the worker $35.3 million in damages in the first phase of the lawsuit.
Read the entire article HERE
Denmark to Improve Monitoring System of Medical Devices
A recent incident where a patient received a hip replacement which was implanted with a cement that had not yet been approved for humans and did not perform its function properly, cause serious injury to the patient.
This resulted in criticism by the Technology Council, stating that 'it is too easy to market substandard products in Denmark to the detriment of patients and the majority of device manufacturers'.
Tightening of controls was suggested, to which the Danish Health Minister, Mr. Arne Rologhed responded with implementation measures to improve control of devices plus and increase in the 2002 budget allowing the competent authority, Danish Medicines Agency (Laegemiddelstyreisen), to monitor manufacturers more thoroughly.