Read This First: Essential Aspects for Medical Device Prototyping
It is tough to find a validation and control protocol as strict as the one used for medical device prototyping. Designing and developing the product is not simply a matter of course. Potential risks, failures, and health-compromising conditions must be identified and addressed. At RexMed, we have the experience to help you navigate this process. […]
FDA GMP incoming inspection: What to check before you start manufacturing medical devices
Before any product leaves your production line, your organization must prove that every quality process works as intended. FDA GMP readiness goes beyond inspection. It builds a culture focused on control and traceability. Performing a proper incoming inspection ensures materials meet specifications before production. Whether you are a startup preparing for your first launch or […]
How to select a company when looking for Medical Device Design and Development
Selecting a partner for Medical Device Design and Development and reverse engineering is a critical business strategic decision. This partner will act as the guardian of your intellectual property, regulatory viability, and the cornerstone of your commercial success. A good choice will hasten your time to market, but making a mistake can result in both […]
Nearshoring Benefits for High-Volume Hospitals and Clinics
Following disruptions like pandemics and geopolitical shifts, medical institutions are seeking stability. Additionally, they need to reduce costs and lead times for obtaining critical medical supplies and devices. For those reasons, the hospital supply chain is under immense pressure. The solution lies in nearshoring within the healthcare sector, utilizing certified suppliers in the U.S. and […]
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 […]