The materials will discuss IT security in the context of an overall organization security program including the value and approach of an IT security vulnerability test.
Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.
Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.
The entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.
You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices.
Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers […]
Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.
Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality. The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance […]
Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have […]