All Blog Posts Tagged 'healthcare' (109)

The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.

The healthcare and wellness industry is shifting toward regulated, personalized,…

A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.

Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection?…

The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no place on this planet that this industry does not cover. You are as likely to find a food joint in Mongolia as you are in Mozambique. The reason is simple: we can live without many things, but not without food. Any surprise that this industry is a giant,…

Healthcare compliance trainings are undertaken to get a clear idea about the regulatory compliance requirements in the industry. Healthcare is a highly regulated industry, which means that the regulatory bodies keep issuing regulatory guidelines, standards or requirements from time to time, as the regulations come in. One question that could arise in the minds of readers is: is it necessary to get trained…

Food inspections occupy a position of primacy among the FDA’s list of mechanisms aimed at maintaining and enhancing food safety. Since it is the sole regulatory body in the US for food, it is natural that the FDA attaches the highest importance to ensuring the safety and efficacy of food that is consumed across the nation.

Towards ensuring this, the FDA has initiated a number of plans and strategies. A seamless, informal and micro level activity in this list is risk-based food…

It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is…

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.

This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the…

A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).

A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and…

All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.

Security Officers or Compliance Officers have their task cut out when it comes to HIPAA implementation. With the changes taking place at the Health and Human Services (HHS) in relation to HIPAA enforcement; both Covered Entities and Business Associates need to insulate themselves from being vulnerable to audit risk. Any small letup will allow individuals whose PHI has been wrongfully disclosed due to bad IT or internal…

As health information grows, sharing it among healthcare providers and researchers is necessary for providing and advancing healthcare services and healthcare research. But the Health Insurance Portability and Accountability Act (HIPAA) of 1996 severely limits how Protected Health Information (PHI) can be shared. It also has restrictions regarding how to protect it…