Keeping Me Safe / Monica K Chibber

Keeping me safe

Monica K. Chibber

Country : USA

With standards, products are made more efficiently, with fewer risks and defects.Imagine that your company designs an innovative new medical device which has the potential to save the lives of millions. You are excited to introduce your new product to the world, but, before you can begin distributing to overseas buyers, you must comply with all the standards and regulations. You ask yourself : is this really necessary ? Why do I need more paperwork ?
I have some nine years’ experience in the pharmaceutical and medical device industry (from drips, needles and infusion pumps to dental imaging devices). I am specifically interested in quality and regulation, and I am currently a regulatory affairs specialist with a medical device manufacturer of oral fluid diagnostic and collection devices.
Further investigation changes your perspective on the new requirements and “ paperwork ”. Many standards such as ISO 14971 on risk analysis for medical devices and ISO 13485 on quality management for medical devices contain key elements for producing a safe and effective product. These standards will make sure that a doctor can use your product with confidence, and that no undue harm will befall the patient. The intended purpose of saving a person’s life will be achieved with no negative repercussions. This is where you realize that International Standards are not only necessary, they are also a blessing in disguise, which will protect the public and your company.
Every day we unknowingly utilize objects that must comply with International Standards. It is these standards that prevent useful equipment – from your cell phone to the X-ray machine at the dentist’s office – from becoming a health hazard.
Standards and regulations cover a wide array of products to ensure safety, reduce waste, and lower costs. Above all, they uphold public safety. And when public safety becomes a priority, manufactures will benefit from producing quality products.
With standards, products are made more efficiently, with fewer risks and defects, which in turn increases production and profit. International Standardsare used to create a safer environment  for everyone worldwide. They may go unnoticed in the background of our everyday lives, but it is  thanks to them that we don’t have to think twice about talking on our cell phones, microwaving our food or driving our cars.