Many people had to transition to a remote work environment amidst the COVID-19 pandemic, with Notified Bodies being no exception. This meant that medical device companies had to be audited virtually, which left many unsure as to how successful a...
If you are a part of the medical device industry, you are probably familiar with just how many “must know” acronyms exist. Three of the most important, and most often confused, acronyms are DHF, DMR, and DHR. The Design History...
Design of Experiments, or DOE as it is commonly known in the industry, is defined as a “branch of applied statistics that deals with planning, conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of...
Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due to the COVID-19 pandemic, there is an unprecedented number of EUA devices on the market, with many products being manufactured by...
[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][/vc_column][/vc_row][vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern" z_index="" css=".vc_custom_1535561699748{background-color: #ffffff !important;}"][vc_column width="2/3" css=".vc_custom_1535735592172{padding-right: 75px !important;padding-left: 75px !important;}"][vc_empty_space][vc_column_text]This webinar will explore the Medical Device Single Audit Program, or MDSAP. We will provide an...
The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in turn allows similar devices to leverage the De Novo device as a predicate. In recent years, the De Novo pathway has proven to become much...
Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring that they continue to monitor the safety/effectiveness of the manufactured devices that are on the market. The requirement for post-market surveillance (PMS) was implemented...
Every medical device company should be familiar with the terms design verification and design validation. You will normally see these terms grouped into what is colloquially known as “V&V” activities, but medical device firms must understand the difference between the...
On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly...
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA...