Rapid Prototyping Capabilities  The practice of Rapid Prototyping requires different toolsets for a mechanical engineer than for a software engineer or industrial designer.   But no matter what type of product you’re building, the technique can be vital in the development process by enabling early on...

Realtime Expedites Path to Production Electronics manufacturers are currently experiencing a global shortage of electronic components. This shortage is forecast to last through 2018 and potentially into 2019.  While the market is accustomed to experiencing longer lead times associated with memory chips, FPGAs, and microprocessors, the...

Per the RAPS Regulatory Focus newsletter, the FDA is considering mapping the applicable FDA device Quality System Regulations (QSR) in 21 CFR 820 to the appropriate ISO 13485:2016 clauses. Reportedly, this change is due to the current global harmonization initiatives regarding quality management systems. The FDA...

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...