Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance. What makes preparing premarket submissions that win regulatory approval […]

Management for Medical Device Industry

  A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent […]

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is […]

HIPAA survival needs intimate knowledge of the nuances of the law

HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need to know exactly what to do in order to pass a […]

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies. ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines for […]

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions. Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to […]

Assessment-based prediction is an effective tool for hiring the right candidate

Undoubtedly, hiring should rate as being among the most important activities for an organization. This is so because it is through this process that the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up […]

Getting overtime pay calculation wrong can be damaging for the employer

A thorough grasp of the subtleties of the Fair Labor Standards Act (FLSA) continues to elude many employers, even though this Act has been around for a long time. The frequent changes that keep happening to the many regulations of the FLSA from time to time are one of the major reasons for this. These […]

The interconnectedness between human resources and project management

Although a superficial look may suggest nothing in common between HR and project management; upon scratching the surface a bit, one discovers a close relationship between the two. Project management and HR are very closely related to each other, if one considers the similarity in the approach to the two disciplines: Project management is rooted […]

Assessment-based prediction is the basis to good candidate hiring

Hiring is among the most important activities for an organization, because it is the process by which the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with […]