The FDA graciously extended the deadline for IEC 60601-1-2:2014 (Edition 4) compliance beyond its original April 2017 due date to December 31st, 2018 to match the European Union deadline, but don’t let the later date lull you into a false sense of security; it is...

The FDA just released their latest guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm482649.pdf). The FDA position on this topic fits largely into the Medical Device industry expectations.  Where your device has an electronic interface that is intended to exchange data...

At The Realtime Group, we have seen the demand for connectivity with endpoint devices increase exponentially, which introduces greater challenges in power management, bandwidth, cyber security, and radio interference. Use case requirements are driving more complex interfaces, often with multiple channels and/or connection mediums. Whether...

The RoHS directive restricts hazardous substances that may be contained in Electrical and Electronic Equipment (EEE).  The new RoHS Directive 2011/65/EU, better known as RoHS 2, went into effect on January 2, 2013.  But what does this mean for the Original Equipment Manufacturer (OEM)? Article 7 of...

ISO 13485:2016 was released earlier this year and, to remain certified, companies will have to transition by 2019.  These next few years will be quite interesting in the device world between this release, the EU in vitro diagnostic and medical device regulations coming, updates to...

Good question. The answer is, ‘It depends’. It depends on the ‘Intended Use’ of the software, the criticality of the application, and the resulting classification given all the facts of its use. Implied  in this is the intention of the manufacturer who created and marketed...

Today, The Realtime Group is announcing our new facility Open House to occur on May 25th 4:30-7 PM at 5217 Tennyson Parkway, Suite 200, Plano, TX 75024. Please join us for a facility tour, product and development environment demonstrations, direct interaction with our professional engineering...