Risk analysis plays an important role in the development of medical devices design.
Internal risks include that do poor systems or poor performance by employes, that will lead to accidents in the production facilities, operational inefficiency and low-quality products.
On the other hand, external risks do fall under the operational risks. One of the categories of external risk is economic risk, that do affect all the business with economy, change in the internal or external risks.
The way I see it is that internal risks are like the name suggests, it exists inside or within the company. Hence a few examples could be operational risks (day-to-day operations or equipment or processes), financials risks (funding for departments, budgeting) or compliance and regulatory (sorta external but standards within the company is what I'm referring to here). External risks include; the market (competition or technological advancements), regulatory changes (now this is what you might be thinking of originally) and Supply chain risks.
