Sara Moly

Medical equipment is meant to help patients, not harm them. This is why Europe demands that all equipment meet certain expectations prior to their usage in medical facilities. Fortunately, there are...

Know about FDA drug establishment registration by studying the rules and regulations for it online. Besides registering your drug establishment with the FDA, this service offers a wide range of...

If you’re in the business of designing and producing medical devices, then you’re probably familiar with the importance of the CE marking certification, and you may even know just how difficult it can...

In a majority of companies it is mandatory to not only manufacture and sell certified medical equipment but also to mark it as such. This designation gives vendors and individuals peace of mind that...

The regulatory requirements for drugs and medications are very strict so it behooves the manufacturers to ensure that they have everything in place before marketing and distributing to prevent the...

The United States has some of the strictest regulations when it comes to prescription drugs, OTC medications and any type of product that can be ingested or applied to the body. The FDA is the...

If you are wondering how one can benefit by ISO 13485, then you may have some interest in the below article.Wondering where to find key information pertaining to the subject matter of ISO 13485:2012...

If you are searching for some valuable information with regards to medical and data testing then you may want to continue reading through the below sections where we shall illustrate some of the...

The CE certification process can be extremely overwhelming without the help of a professional team that knows the process well. This is the quickest, most effective method for obtaining the most...

If you are searching for some information with regards to ISO 13485:2012, then you may benefit by glancing over the following article. Although there are many certifications within the health sector...

Medical devices must follow the regulatory requirements of 21 CFR 820 to be considered within compliance. These strict guidelines assure adherence to federal regulations via audits.There are...

DMF can help you protect your firm and your intellectual property from your partner, but you must do so in a way that meets all regulatory requirements. There are five types of Drug Master Files in...