#Texnicle file manual
#Texnicle file iso

Many companies fail to give themselves a good base of established design controls and a DHF. Your design controls will feed into many of these sections. It contains 20 sections for different things like device description, indications of use, and performance. A good part of the 510(k) is to also demonstrate your product is safe and it works. The aim is to demonstrate to FDA that your product is substantially equivalent to a predicate device, a product that has been previously cleared by FDA. A 510(k) is required for most Class II devices (and some Class I and Class III some Class II do not require 510(k)). The 510(k) submission is the common path for medical devices to gain market clearance from FDA. I wanted to start with the DHF and your design controls because they really form the basis that feeds into the 510(k) and technical files. With electronic-based quality management systems, the creation of the DHF has become a much easier task.

#Texnicle file manual

Maintaining a DHF is most commonly a very manual process, involving old-school three-ring binders, filing cabinets, and paper. This is important because your design controls are your records demonstrating your product is safe. The DHF now has more emphasis because it is acknowledged as a key file containing design control documentation.

#Texnicle file iso

However, the updated ISO 13485:2016 now specifies the need to establish “design and development files”. ISO 13485:2003 made no direct mentioned of a DHF, or something similar. Until recently, a DHF was technically only a requirement defined by FDA. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of this part.” Per FDA, “Each manufacturer shall establish and maintain a DHF for each type of device. This is simply the collection of documents from the design and development process. The design history file is an FDA term described in 21 CFR Part 820.30, which talks about design controls and how they must be kept in a design history file (DHF). However, if you have good background knowledge, I think you will find there are similarities between each. There are three types of files specifically that cause a great deal of confusion: the design history file, 510(k) submission, and the technical file.Īs with any kind of files in medical device development, these require a lot of effort. There are so many different technical terms, documents, and acronyms you need to know working in the medical device field.