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Medical Device Engineering

Accelerating Product Development the SPK Way

Accelerating Product Development the SPK Way

Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...

ROHS 2 for Medical Devices: Are You Ready?

ROHS 2 for Medical Devices: Are You Ready?

As of July 22, 2014, the RoHS (Restriction of Hazardous Substances) Directive must be observed for first time distribution of all medical devices to the full extent. Furthermore, all products with a CE marking must also be RoHS-compliant. ROHS 2 Compliance Changes at...

The FDA UDI Rule: 5 Things You Need to Know

The FDA UDI Rule: 5 Things You Need to Know

The release of the FDA final rule on Unique Device Identification (UDI) is expected this summer. Here are five things you need to know: 1. What is the UDI Rule? In July 2012, the FDA proposed a rule requiring medical device manufacturers to label their products with...

FDA Form 483: Top Ten Observations for Medical Devices

FDA Form 483: Top Ten Observations for Medical Devices

Medical Device manufacturers regulated by the FDA are subject to cGMP (Current Good Manufacturing Practice) regulations and may be inspected by the FDA to ensure compliance. If the FDA inspector(s) observes conditions that in their judgment may constitute violations,...

Accelerating Medical Software Compliance and Efficiency with SPK ACEs

Accelerating Medical Software Compliance and Efficiency with SPK ACEs

Compliance with regulatory standards is the number one priority for every medical manufacturer.  Ensuring pipelines are secure and compliant doesn’t just ensure safety, but it results in better quality products.  When a startup medical manufacturing company contacted...

A Breakthrough in Custom Medical Implants with Creo

A Breakthrough in Custom Medical Implants with Creo

New medical approaches combined with innovative technologies are transforming how medical professionals treat patients. In this case study, we will explore how a young patient’s life was changed through the use of PTC Creo’s extensive capabilities.  “Bioactive printed...

Strategic Partners, Not Just Extra Hands

Strategic Partners, Not Just Extra Hands

Today’s business environment requires companies to align with best-in-class vendors to be true, strategic partners.  They need partners who understand their industry, their challenges, and their long-term goals.  In the years we have partnered with our clients, some...

Agile Software Development and Jira Software

Agile Software Development and Jira Software

Unlocking the Power of Collaboration and Efficiency Tired of trying to overcome the pain points of traditional software development methods? Frustrated with slow project delivery? Struggling with team collaboration? Version control nightmares? Worry no more. You can...