If you’re a medical device manufacturer – and especially a smaller one, such as a recent start-up – the real question might be “How can you NOT outsource quality assurance?” Smaller firms such as start-ups are especially vulnerable to issues surrounding quality...
If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data...
Last year the US medical device industry achieved over $150 billion in sales, making it one of the most lucrative industries in the country. However, launching a medical device start-up in this highly regulated industry can be fraught with challenges. Medical product...
Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing...
Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do...
One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement...
US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device...
For those who may not be entirely familiar with the Medical Device Single Audit Program (MDSAP), this initiative is intended to allow auditors from MDSAP-recognized Auditing Organizations (AOs) to conduct a single audit of a medical device manufacturer’s quality...
Both the medical device industry and international regulators have witnessed the growing need for a standardized, worldwide approach to auditing and monitoring medical device manufacturing. A single, comprehensive process would reduce costs and speed time to market....
MEDDEV 2.7.1 and what it means for clinical evaluations and reports If you are a medical device manufacturer planning to sell your devices in Europe, you’re aware by now that there have been significant changes in EU regulations recently that affect how medical...