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Medical Device Engineering

Managing a Software Bill of Materials (SBOM)

Managing a Software Bill of Materials (SBOM)

The FDA's heightened cybersecurity standards, implemented in October 2023, have changed submission requirements for medical devices. In this blog post, we'll explore the key updates and detail key information about effective Bill of Materials (BOM) management,...

Design Controls Best Practices for Medical Device Companies

Design Controls Best Practices for Medical Device Companies

Ensuring regulatory compliance and fostering trust in products are paramount for medical device manufacturers. The FDA, European Competent Authority, and Health Canada closely oversee design, development, and manufacturing for patient safety and efficacy....

Shifting from FDA 21 CFR Part 820 to ISO 13485

Shifting from FDA 21 CFR Part 820 to ISO 13485

In this Vlog, Chris McHale, Co-founder, and CEO of SPK and Associates is joined by Carlos Almeida, Vice President of Engineering. Together, they’re discussing FDA compliance and the recent shifts impacting medical device companies. Topics for discussion include...

Introduction to ISO 14971:2019 for Medical Device Compliance

Introduction to ISO 14971:2019 for Medical Device Compliance

Navigating the complexities of ISO 14971:2019 can be challenging. But, with this eBook presented by SPK and Associates and PTC, you're taking the first step towards expertise in medical device compliance. What's In The ISO 14971:2019 eBook This comprehensive guide...

Emerging Trends in Risk Management for 2024

Emerging Trends in Risk Management for 2024

There is a paramount importance to staying ahead of new risks. After all, more and more crop up each day as technology and processes change. So, in this  blog post we’re exploring the 2024 trends for risk management.Why Manage Risk? It sounds like a simple question...

The Power of Trend Analysis in Drug Development with eQMS Platforms

The Power of Trend Analysis in Drug Development with eQMS Platforms

There is an intrinsic value of identifying trends in data for medtech manufacturers. Yes, the prospect of avoiding scrutiny from federal auditors is a tangible benefit. However, the true motivation for proactive medical device trend analysis lies in its power to...

Medical Device Trends For 2024

Medical Device Trends For 2024

2020 was a wild ride, especially for the medical device world. The pandemic shook things up, making everyone scramble to adjust to a new way of doing things. Now, four years later as we peek into 2024, the medical device scene is still changing. This blog post will...

The Tools For ISO 14971 Compliance for Medical Device Manufacturers

The Tools For ISO 14971 Compliance for Medical Device Manufacturers

The journey from concept to market-ready medical device is no easy feat. The regulatory economy, development and legislation is intricate. Understandably, compliance with standards is non-negotiable to ensure the safety and efficacy of medical devices. One such...