What these five things about the new European Medical Device Regulation (MDR) mean for you

With the Date of Application of the new European Medical Device Regulation (MDR) going into effect in less than two months, change is coming to medical device manufacturers who sell into the EU. This new requirement is likely to impact how medical device manufacturers operate, increase their compliance costs, and significantly alter their change management [...]

Does Your FDA GUDID Process Comply with FDA 21 CFR PART 11?

WHAT IS FDA 21 CFR PART 11? FDA 21 CFR PART 11 (Part 11) refers to electronic record-keeping in FDA-regulated industries, ensuring electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. FULL AUDIT TRAIL Part 11 compliance stipulates that electronic records be created, modified, or deleted securely, with each entry [...]

EUDAMED delayed, but DoA remains May 2020. Implications for device manufacturers.

MDR requirements (other than EUDAMED reporting) come into force on the Date of Application (DoA)- 26 May 2020.  Numerous MDR clauses address transition issues and new regulations that do not involve reporting information to EUDAMED.  Some of these requirements are listed below: Transition from MDD to MDR Certificates Directive certificates (MDD/AIMDD) cannot be issued or [...]

UDI for the EU MDR: What you need to know

In less than 12 months, the new European Union Medical Device Regulations (EU MDR) go into effect.  All Medical Device companies that wish to sell their products into the EU will have to meet these new requirements.  As the date approaches there has been much confusion regarding what is involved, which parties are responsible, and [...]

Nurses prefer smartphones over mobile computers. Is it a safe choice?

Bring Your Own Device (BYOD) emerged when workers preferred the convenience of using their personal smartphones for business. Employers appreciated the cost savings, but security issues and durability have become a major concern. In hospitals, where regulations like HIPAA require patient privacy, is a consumer smartphone a safe choice for enterprise computing? Studies show that [...]

One size doesn’t fit all: Choose the right patient wristbands

Patient safety has been a critical priority for healthcare organizations, even before The Joint Commission first introduced the National Patient Safety Goals (NSPG) in 2003. Barcode technology has proven to meet the criteria for preventing errors that result from incorrect patient information. The NSPG specified that at least two patient identifiers must be used whenever [...]

Move your specimen collection labeling to the point of care

Nearly 161,000 adverse events occur in U.S. hospitals every year as the result of medical errors in identifying specimens; 37% of the errors occur during the collection process. In spite of the advances of automated data collection, some areas of healthcare haven’t yet embraced barcodes and mobility. Tasks like specimen collection become more accurate and [...]

Improve the health of your medical labels

Every industry faces its own unique challenges when it comes to labels. From compliance standards to packaging material and environmental conditions, every label must meet its own set of requirements. In a hospital or healthcare organization, hygiene is a tantamount concern. Specimen labels, equipment asset tags, and patient wristbands must withstand the constant cleaning with [...]

Maximize the patient safety potential of a wristband

Patient safety begins at admission. From this first engagement to discharge, the patient needs the protection of an accurate, durable wristband. For the most protection, rely on the accuracy of barcode technology. Positive patient identification was listed as one of the top 10 patient safety concerns in the latest ECRI Institute report. The Institute’s Patient [...]

4 Technology Trends Every Manufacturer Needs to Remain Competitive

We are seeing some exciting trends in the automatic data capture space that can help your business improve productivity and profitability. Let Coridian help you explore these technologies and see how they can move your business forward. Here are the trends: Transition from 1D to 2D Scanning Mobile Operating System Migration - From Windows to [...]

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