Balancing structure and flexibility in medical device development requires developing an approach that fits organizational structure with project needs while maintaining regulatory compliance and inno...

Filing for FDA approval of a misclassified device can cause major hinderances to the entire process, whether the company filed a class II device as class III or the other way around. The time from sub...

Organizations can find a balance between regulatory compliance and innovation without compromising agility by practicing open communication, involving regulatory experts early in the development proce...

When considering using new technology in a project, the PM must take into consideration the impact to the overall cost and timeline of the project. If the new technology is extremely expensive and wil...

A strong regulatory strategy is essential for effective project management in the medical device industry, as it reduces risks such as costly delays, failed approvals, or market withdrawal. One of the...

The biggest regulatory challenge in developing emerging medical technologies involving AI or machine learning is finding a balance between adhering to strict regulatory safety standards and finding fl...

A project manager can keep project goals dynamic while avoiding scope creep and ensuring successful delivery by establishing a strong framework for continuously updating goals as they change and commu...

When it comes to working within a team virtually, I find that the best way to effectively communicate is finding the right platform and giving everyone enough time to engage. The first aspect of team ...

In my opinion, a balanced combination of in-person and virtual communication can be used in successful project management. I do not think it necessary to go all in on either method of communication, b...

Verbal contracts are much less common than written contracts in the medical device industry, but they can be important in situations where an immediate agreement or quick decision is required. Compani...

To keep up with the shift toward value-based healthcare, medical device companies should prioritize patient outcomes, operational efficiency, and working closely with healthcare stakeholders. One appr...

Risk management is extremely important to the medical device sector. Here are a few examples of each of the 4 strategies discussed in the lecture related to a hypothetical heart implant company: Risk ...

There are ISO and FDA standards that frame how risk management should be handled when it comes to medical devices. According to ISO 14971, risk analysis should include identifying potential hazards an...

When companies interpret standards like ISO 13485 and 21 CFR 820.30, several factors influence their approach. These interpretations show the balance between strict regulatory compliance and the compa...

Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and validation ensures that the design meets the user needs....