Risk Management in IEC 60601-1 Third Edition

Risk Management in IEC 60601-1 Third Edition Risk Management is a critical factor in IEC 60601-1 Third Edition. This is one of the important additions that have been made to this edition from the previous one. The new legislation requires that Risk Management be implemented in the product lifecycle throughout the standard. Risk Management at […]

Medical compliance

Medical compliance Medical compliance, rather lack of it, is perhaps the most detested word for the medical fraternity. Medical compliance is, in simple terms, adherence to prescribed treatment. Many patients fail their doctors by not following treatment courses properly. The reason most people do this is that they feel better after a few doses, and […]

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 […]

Getting IEC 60601-1 3rd Edition Certification

Getting IEC 60601-1 3rd Edition Certification Major clause The IEC 60601-1 Third Edition has a major clause. This is an addition to the existing regulation. Accordingly, an electronic medical device has to conform to the ISO14971 regulations, which relate to risk management. According to this regulation, a medical device manufacturer has to implement risk management […]

History of FDA GMP requirements

History of FDA GMP requirements The FDA has Good Manufacturing Practices (GMP) requirements for a range of items. One of them is Active Pharmaceutical Ingredients (API). FDA GMP requirements are established under the FDA Act. In Sec. 501 (a) (2) (B) of the Act (21U.S.C. 351(a) (2) (B)); the FDA seeks to establish API as […]

FDA API GMP requirements –current quality guidelines

FDA API GMP requirements –current quality guidelines The US FDA has set out Good Manufacturing Practices (GMP) requirements for a number of products. The Food, Drug and Cosmetic Act, a US law,empowers the FDA with authority to regulate a number of industries. Accordingly, the FDA GMP requirements and guidelines exist for a clutch of products […]

Essential Performance requirements under IEC 60601-1 Third Edition

Risk Management has been considered a critical factor in the revised IEC 60601-1 Third Edition. Not only does the new standard require that Risk Management be implemented in the product lifecycle throughout; it also requires complete adherence to ISO 14971, the ISO standard on risk management in medical devices. “Essential Performance vs. Basic Performance” Another […]

Compliance Webinars

Looking for compliance webinars? Compliance webinars educate participants about compliance. This education is needed because many companies work on products that need compliance as set out by regulatory bodies such as the FDA. When looking for compliance webinars, try to keep these points in mind: Why are they needed? Most compliance webinars are for experienced […]

API Process Inspection –what does the FDA expect?

    API Process Inspection –what does the FDA expect? Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to. The FDA and API Process Inspection Rules regarding what the FDA expects are […]

API Process Inspection –what does the FDA expect?

    API Process Inspection –what does the FDA expect? Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to. The FDA and API Process Inspection Rules regarding what the FDA expects are […]