Labeling and Packaging Compliance: How to Pass Your Next FDA or ISO Audit
Passing an FDA or ISO audit is more than submitting paperwork. It requires a culture of precision, transparency, and full traceability. Every label, barcode, and package must connect seamlessly to manufacturing records. Compliance failures can delay approvals, harm a company’s reputation, and lead to costly recalls. For over three decades, manufacturers like Rexmed Health have […]
Smart Custom Medical Devices: From Design to Scalable Manufacturing
The demand for custom medical devices is increasing as medical attention shifts toward patient-centered care to achieve its objectives. Personalized and smart devices present themselves as cost-efficient and satisfying solutions for a technologically evolving field, such as medical equipment. This tendency necessitates a new approach to performing all tasks in the production chain, from design […]
Selecting the Right Binational Manufacturer: Key Criteria Beyond Compliance
Finding a binational manufacturer is a strategic decision in the medical device industry. And while regulatory compliance is essential, the most forward-thinking companies understand that the factors that truly define a strong partner extend beyond this. This article examines the five key criteria that companies must consider when selecting a partner. However, it’s not just […]
What a Strong Supplier Case Study Should Include
A supplier case study provides evidence to review production partnerships in medical device development. These papers demonstrate the abilities, rules, and process methods that determine how well projects perform and how they adhere to established guidelines. Why Supplier Case Study Is A Strategic Tool in Vendor Evaluation Analyzing a strategic supplier case study enables OEMs […]
In-line testing and quality assurance: preventing FDA market access risks
In-line testing is a crucial process for achieving success in medical device manufacturing. Operating in this sector demands the constant scrutiny of the Food and Drug Administration (FDA). Even a single failure in quality standards can result in a market rejection. For this reason, as manufacturers, we must adopt proactive quality by implementing strict controls […]
COFEPRIS Certification Explained: Step-by-Step Process for MedTech Exporters
What is COFEPRIS certification? It’s essential if your company is willing to compete in international markets. While there’s no doubt that the MedTech business offers numerous opportunities, it is also necessary to be aware of several regulatory requirements. At RexMed Health, we are committed to helping partners stay aligned with Mexican and international regulatory standards, […]
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 […]