Certified or not? How to know if your contract manufacturer truly delivers quality
Every company owner needs a certified manufacturer who delivers quality. Choosing the right one can be challenging at times due to multiple factors, such as verifying certifications, aligning with your product’s needs, or assessing actual quality. That’s why you have to ensure that your manufacturer is a reliable supplier, certified, and efficient. With the perfect […]
IQ, OQ, PQ Process Validation: What They Are and Why They Matter
In the medical fabrication industry, process validation is not a luxury but an indispensable obligation. It guarantees that equipment and procedures operate in a balanced manner, delivering products that meet all required details and regulations. Process Validation: Defining IQ, OQ, and PQ in the Medical Manufacturing Context Process validation in the medical manufacturing units consists […]
Dual Certification Compliance: Meeting NOM and FDA Standards Without Duplicating Efforts
Manufacturers often pursue dual certification as a strategic approach to meet both Mexican NOM-241 and FDA 21 CFR Part 820 standards simultaneously. This approach eliminates unnecessary work and ensures they are fully compliant in all North American markets. Today’s medical device manufacturers face considerable pressure to enter various markets and maintain operational efficiency quickly. Regulatory […]
Cleanroom Assembly: The New Standard
Cleanroom assembly is a critical procedure that guarantees maximum environmental purity during the fabrication of sensitive products. This controlled location is essential for avoiding corruption and ensuring quality in high-value industries. How Cleanroom Assembly Improve Product Safety and Inspection Outcomes Cleanroom assembly provides an invisible shield that protects the most sensitive elements from their most […]
OEM vs CMO Manufacturing Models: What Does Your Company Need?
Choosing the right production strategy represents one of the most critical decisions for medical device companies. The comparison between OEM vs CMO models shapes cost, compliance, and market success. Executives must evaluate scalability, quality control, and long-term competitiveness before selecting a path. The optimal production approach influences time-to-market, operational efficiency, and return on investment. Understanding […]
How to scale medical manufacturing without losing compliance
Bringing a medical device from concept to market is a complex journey. Early pilot runs feel manageable because quality checks are easier to oversee and manage. However, when companies begin to scale medical manufacturing, every new process, supplier, or machine introduces additional complexity. Scaling introduces regulatory and operational pressure. Market demand, investors, and competition often […]
Flexible Manufacturing: The Ideal Model for OEMs Requiring Precision
Flexible manufacturing is redefining how OEMs respond to dynamic MedTech markets. It empowers accurate production, without compromising anything—specifically, elements such as governance, traceability, and product excellence. However, not everyone is aware of how it works. In this article, you can discover how this transformative model enables medical device manufacturers to navigate shifting market needs. All […]
Protecting IP When Nearshoring Medical Manufacturing
The importance of IP protection while nearshoring lies in one simple fact: it makes your company unique. In an increasingly competitive market, being different is what sets you apart. Are you going to let someone take that away from you? How can you ensure that your company’s secret sauces remain safe? You may find this […]
The Future of Medical Devices Under USMCA: What You Need To Know
The current USMCA agreement establishes measures that support the medical device manufacturing industry and exports through precise regulatory alignment and tariff benefits. Notable improvements, such as a complete duty-free allowance for qualifying products, unified criteria, reduced costs, and a single audit system, promise to contribute to the sector’s thriving growth. Other key elements, such as […]
Why Class II Medical Devices Require Stricter Validation
FDA validation is mandatory for Class II medical equipment due to its moderate-to-high risk outline. This practice certifies compliance with regulations and the security of medical devices that directly impact patient health. What Sets Class II Medical Devices Apart: FDA validation The FDA institutes specific and strict requirements for these products due to their elevated risk […]