In a standards-based industry that is not so standardized… Everyone involved in Global Market Access (GMA) knows how complex it can be to handle regulations, clients, test labs, certification suppliers, and local authorities in a fragile balance. Multiple channels of communication, countless certification applications, and a reserved space in our brains to keep track of…

Insights from an Global Market Access Industry Expert In the ever- changing world of Global Market Access (GMA), meeting production and launch deadlines can feel like navigating a maze of lead times, certification requirements, and logistical challenges. As someone with over ten years of being deeply entrenched in project management and operations within this industry,…

Ensuring safety and meeting regulatory standards are pivotal in the rapidly evolving landscape of product development and manufacturing. For Global Validity, the Medical Equipment Compliance Associates (MECA) stands as a trusted ally, offering unparalleled expertise and comprehensive solutions in compliance and safety assurance. At MECA, safety expertise is at the core of their mission. They…

Obtaining global regulatory certifications for wireless products is a demanding task. The process can be long, costly, and require significant resources to support and manage. Automotive industry manufacturers of wireless technologies such as infotainment systems, telematics devices, sensors, etc. are particularly challenged as these types of products typically require multiple types of certifications (Radio, Safety,…

In the fast-paced world of product development and manufacturing, ensuring safety and regulatory compliance is paramount. Global Validity has found a trusted ally in Product Safety Consulting (PSC). Since 1988, PSC has been a beacon of expertise, guiding businesses through the intricate maze of product safety and regulatory standards efficiently and cost effectively. Key Partner…

There are a several industry myths that surround renewing expiring country certifications. It really starts with the term “renewal.”  In most cases, manufacturers are actually required to re-certify products that have expiring country certifications by submitting new applications. It is rare for a country to offer an amended certification process for expiring certificates. This means…

Implementation of SAR Testing in Indonesia Indonesia’s Certification Body, SDPPI, has announced implementation dates for in-country SAR testing requirements. The following devices are required to test locally for SAR if the device operates 20 cm from the body and has a transmit power of more than 20 mW. SDPPI has not yet qualified a test…

Managing the Lifecycle of Product Certifications Have you just completed certifying a product globally? Congratulations!   Completing the global product certification process is a remarkable achievement, but the journey doesn’t end there! Did you notice that many of the certifications expire? Post certification management is a mission critical responsibility for manufacturers.   The Importance of…

When global product compliance is an afterthought, manufacturers run the risk of not meeting international requirements that may result in launch delays, additional testing costs, or even a product redesign. Engineers that have experienced this pain typically do not repeat it. They understand the value of a detailed compliance strategy that proactively prepares the manufacturer…