Advocate General Opinion on Software Medical Devices

On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices. The AG’s opinion is […]

Validation of Pharmaceutical Water Systems

Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals. A very important reason for which validation of pharmaceutical water […]

Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it […]

Regulatory Filing Requirements for medical devices in Japan

  Japan is the world’s third largest market for medical devices, after the US and Europe. Ironically, many of the world’s medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are relatively less complex […]

Medical device regulatory compliance training

For any professional in the medical devices industry; training is a must. This training has to be on the regulatory aspects of the industry profession, because this is at the root of the profession. Medical devices being one of the most regulated industries, a professional in this industry is governed by a slew of regulations. […]

FDA guidance

FDA guidance AnFDA guidance, as the title suggests, is a set of suggestions from the FDA on a number of its governing areas. The FDA, being a regulatory body sets standards for almost every conceivable area. It is almost impossible to list the number of guidances the FDA has issued. Nonbinding in nature Guidances are […]

IEC 60601-1 Third Edition –introduction and implementation dates

The IEC, which stands for International Electrotechnical Commission, dates its founding to more than a century back, to 1906. It is the world’s leading voluntary organization for regulation of the technologies that collectively go into electronic components and are bunched together as electrotechnology. In setting standards for electronic and electrical gadgets, the IEC regulates, in […]