Medical testing products include diagnostic and treatment equipment used to maintain patient health, such as X-ray machines, surgical lasers, baby incubators, pacemakers, and life support devices. They also include lab equipment for analyzing blood, urine, genes, and dissolved gases in the body. Medical monitoring equipment allows healthcare staff to measure a patient’s condition, such as electrocardiogram (ECG), oxygen levels, blood pressure, and heart rate.

Reusable instruments require decontamination, sterilization, and reprocessing prior to each use. This involves large amounts of water, detergents, chemical disinfectants, specialized cleaning equipment, steam production, and electricity, all of which pose significant ecological concerns. Single-use disposable instruments, on the other hand, do not require these additional steps. Using these less-resource-intensive instruments can help hospitals save money and reduce their environmental footprints by reducing the amount of waste they produce.

A growing concern in hospitals is biomedical waste, which includes supplies and materials contaminated with blood or bodily fluids, secretions, or excretions. Worldwide, hospitals alone generate 4 billion pounds of this waste each year. Proper disposal of this waste is vital, as improper handling and disposal can lead to cross-contamination and hospital-acquired infections (HAI). Single-use disposable instruments made with thermoplastic are a viable option for hospitals to address their growing environmental concerns and cost advantages over reusable devices.

Regulatory bodies around the world have different requirements for the certification of medical devices. In the EU, for example, classification is based on rules that involve duration of body contact, invasive character, use of an energy source, impact on the central or nervous system, diagnostic impact, and incorporation of a medicinal product. Certification is obtained by submitting a technical file and undergoing a device type examination by a Notified Body.

In the US, FDA approval is required for any medical device that is not a drug or biologic. If a medical device is to be sold in the market, it must undergo extensive clinical trials that are carefully designed to answer specific research questions.

Once a product is approved for sale, it must be marked with the CE mark. This mark indicates that the device meets European safety standards, including information on instructions for use, harmonised pictograms, and warnings in several languages. It is also required to carry the manufacturer’s full name and address.

Keeping up with changing global regulatory compliance and auditing requirements is challenging for any organization, especially one working in the fast-paced medical industry. It is important to have the right tools, such as a dedicated, highly experienced team of consultants who understand your business and are able to provide comprehensive support. Whether it’s ISO 13485, MDSAP, cGMP or other regulations, get your medical devices to market faster with a fully integrated, global auditing and certification support network at your side.