Here follows a short blog about Medical Devices and Systems Leader, Sterling Medical Devices, and their development testing successes, led by Vice President of Engineering, Bruce Swope.

Sterling. A word that can either mean a type of high-quality, fortified silver used in table utensils and jewelry, or that describes the British Currency. In addition, it can also convey the sense of “thoroughly excellent”. Sterling Medical Devices fits, without question, into the latter category. Thoroughly excellent Medical Devices, categorized by high-quality software, driven by the company’s development testing efforts, partnering with Coverity. And in the case of Sterling Medical Devices – only the best will suffice.

Sterling Medical Devices specializes in the design, development and testing of medical devices and systems for its clients. The company consults with small and large medical device manufacturers, from the well-established to start ups, in order to develop and deliver highly reliable and safe medical devices.

To continue reading this article please visit the Coverity “Software Integrity Blog”.

FDA and CE Regulations:

Medical devices are covered by FDA regulations in the US and by Medical Device Directives in European Union (EU) countries. Technically, the FDA does not “approve” Class 1 and 2 and some Class 3 medical devices for sale in the US. Instead, they give “clearance” for them to be sold.

The two major processes by which medical devices requires FDA review are:

In order to be eligible for 510(k) clearance, a new device must exhibit roughly the same safety and effectiveness characteristics as a “predicate” device to which the new one is being compared. The PMA process, on the other hand, is based on a demonstration of safety and effectiveness through “adequate and well-controlled” clinical trials. A successful PMA submission results in approval of the new device. An excellent discussion of the differences between 510(k) and PMA can be found at www.devicewatch.org/reg/510k.shtml.

While the FDA requires evidence of both safety and efficacy of a device, a European CE Mark requires only proof of safety and that the device performs in a manner consistent with the manufacturer’s intended use. As a result, FDA Clearance can require as long as 3 years while CEO Marking can usually be obtained in a much shorter time., leading to considerable discussion regarding which path should be sought first. An excellent discussion of this topic can be found at www.mdtmag.com/articles/2012/02/which-way-go-ce-mark-or-fda-approval.

How to Get Your Device through the FDA Process:

Obtaining FDA clearance can be a long and arduous process. It often involves many subjective decisions regarding safety and efficacy. As a result, it is strongly recommended that you engage the services of a reputable submission consultant to help develop a strategy at an early stage. A list of submission consultants can be found simply by typing “FDA Submission Consultants” into the Google search engine.

Throughout the process, it is very important to maintain open communication, getting the FDA involved as early as possible and understanding where your device fits and what they are looking for. It is also important not to overcomplicate the documentation, but rather to stick to the facts and keep it as simple and straightforward as possible. The submission consultant you select can provide valuable assistance with this.

• The mobile application can run on a mobile platform or, it can be a web-based application tailored to a mobile device but is executed on a server.
• The mobile application meets the FDA definition of “device” and either:
  • is used as an accessory to an already-approved medical device
  • transforms a mobile device (smartphone, etc) into an actual medical device

The FDA Guidance document for Mobile Medical Applications can be found here (FDA.gov)

Other special FDA considerations include:

Software Validation:  A mobile application that controls the intended use, function, modes, or energy source of a connected medical device, or that creates alarms, recommendations or new information by analyzing or interpreting data from that connected medical device is considered an accessory to the connected device and is required to comply with the controls applicable to that connected device.

Cyber Security: Security is a concern in the use of RF wireless technology because of the possibility of unauthorized eavesdropping on patient data or access to hospital networks.  FDA recommends that electromagnetic compatibility (EMC) considerations be an integral part of the design and testing of RF wireless medical devices in compliance with voluntary consensus standards such as IEC 60601-1-2:2001.

Off-The-Shelf (OTS) Software: OTS software is subject to the same security considerations as RF wireless technology.  Device manufacturers who use OTS software in a medical device bear the responsibility for the continued safe and effective performance of that device, including the performance of OTS software that is part of the device itself.

Premarket Approval Application (PMA): According to an article in Emergency Medicine News, Class 1 devices do not need premarket review, although they must comply with general manufacturing and registration requirements.  High-risk Class II devices, however, will require a PMA.

Special ISO considerations include:

ISO 62304: FDA has recognized ISO 62304 as a software development standard. The Article “Developing Medical Device Software to ISO 62304 gives a nice overview.

ISO 14971: ISO 14971specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate and control the associated risks and to monitor the effectiveness of the controls.  Its requirements are applicable to all stages of the life-cycle of a medical device.