ProengineerPortal Engineering Services Specializes in
Medical Engineering, Medical Device Design, Development, and Manufacturing

ProengineerPortal has medical engineering service experience to help you develop your next medical device product. Our medical engineering team can design and develop your next noninvasive or minimally invasive medical device instrumentation by providing their engineering services to your company.

Medical Product Biocompatibility

ProengineerPortal’s medical device engineers design medical device products with biocompatibility factored into the product specifications. Every medical device has a material requirement for proposed taking into account environmental impacts. Our material engineers specialize in material compatibility for the human body as well. In other words, our mechanical engineers factor into the mechanical design ergonomic features and benefits.

Food and Drug Administration (FDA) Compliance

Our medical device engineers comply with the regulatory requirements set forth by the United States FDA. Categorization of medical devices marketed lawfully in the United States is based on FDA classification. Medical device classification is determined by the FDA’s decision as it pertains to how the device is used and the level of risk the device has on a patient. Taking the well being and public safety of the end-user (consumer) into consideration are critical factors accounted for by our medical engineering team.

FDA Regulatory Classifications of Medical Devices:

Class I, Class II and Class III are the classifications which are assigned according to the risk a medical device presents to the patient and the level of regulatory control.

Class I medical devices

Of all the medical device classes, Class I devices are regulated the least. This is due to the fact that Class I devices are less likely to cause injury to the end-user, and are often uncomplicated in design relative to Class II or Class III devices. Class I devices are generally manufactured utilizing a more simplistic process as well. Devices in this grouping include some hand-held surgical instruments, sterile tongue depressors, bedpans, examination gloves, and comparable types of general equipment. The majority of class I devices are excluded from the premarket notification. Medical engineering of these devices is the most rudimentary.

Class II medical devices

General controls for Class II medical devices are not sufficient to guarantee product safety and performance. FDA Guidance documents have been produced to ensure effectiveness and safety. Controls sometimes include mandatory performance standards and extraordinary labeling requirements. Special mandatory labeling requirements and performance standards are monitored and controlled both internationally and in the United States. There is also on-going post market surveillance throughout the product life cycle. Medical engineering is critical with this class of medical devices otherwise retributions leading up to product recalls or law suits could ensue. The FDA normally requires a pre market notification and a 510(k) approval before releasing a Class II medical device to market. Essentially, the product specifications must be submitted, reviewed, and approved prior to the FDA allowing a product to go to market. Some Class II devices are free from pre market notification. These exempt medical devices can be found in regulations 21 CFR 862 through 892. Class II devices typically are non-invasive and include x-ray machines, powered wheel chairs, acupuncture needles, infusion pumps, surgical needles and surgical drapes.

Class III medical devices

The most stringent regulatory controls of all are on Class III medical devices. Applications for general and special controls do not provide sufficient information to assure safety and effectiveness. Class III devices are frequently categorized as able to sustain life. These kinds of medical devices are held to a high degree of importance in preventing life threatening scenarios. The FDA typically requires pre market approval authorization before releasing a Class III medical device to market. A small number of Class III devices are only required to have a 510(k) approved by the FDA. Class III devices which call for a pre market authorization include replacement stimulators, heart valves, silicone gel-filled breast implants, and, implantable pacemakers.

Regardless of the class in which a medical device is categorized, all medical devices must be engineered adhering to precise specifications in order to be successful in today’s market place. We, at ProengineerPortal offer the engineering services necessary to help meet the engineering needs of the medical engineering design firm no matter what class a medical device is in.