Quasar passes ISO 13485 Surveillance with no nonconformities

Quasar passes ISO 13485 Surveillance with no nonconformities

In Dec 2016, BSI Auditors pored over DHRs, validations and quality objectives; then toured the lines and reviewed procedures during Quasar’s annual audit. We are happy to announce that Quasar was found ISO 13485 compliant, surpassing requirements in every category.

Following the zero 483 findings of the Nov 2016 FDA Inspection, this is yet another confirmation of the strength of our management and quality systems, reaffirming better outcomes for our customers and their patients.

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Medical Device Manufacturing Risk Assessment

Assessing Risk: 5 Tips for Medical Device Risk Management

What is Risk Management Risk assessment in medical device manufacturing is an ongoing responsibility and must be managed and perceived as a top priority in the organization. Risk management is a framework used to identify, evaluate, and mitigate risk or potential failures throughout a medical device’s development life cycle. It is an integral part of the process of medical device development and manufacturing, utilized to ensure a medical devices’ effectiveness, reliability, and safety for patients and operators alike. Risk Management Standards for the Medical Device Industry Risk management standards for the medical device industry, are defined by the ISO 14971 quality standard, as [...]

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medical device design and development

Medical Device Product Development: Make the Process Work for Your Product

Medical Device Product Development: How to Make The Process Work For Your Product The medical device design and development process consists of four main phases from start to finish of a medical device’s product lifecycle: conception, design & development, technology transfer, and mass manufacturing. The following is a simple step-by -step approach on how to make the medical device design and development process work for your product, pertaining to every medical device design and development process phase respectively. These factors are key to quick and successful time to market. Conception From as early as the product conception phase, care should be taken to [...]

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ISO 13485 Manufacturing

Why ISO 13485 Might Not Be Enough for Your Medical Device Manufacturing Process

ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]

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Design Control Medical Device

A Simplified Introduction to Medical Device Design Control

Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]

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