What is the design history file (DHF)?
The DHF is a compilation of records which describes the design history of a finished device. It covers the design activities used to develop the device, accessories, major components, labeling, packaging, and production processes.
What is the device master record (DMR)?
The DMR is a compilation of those records containing the specifications and procedures for a finished device. It is set up to contain or reference the procedures and specifications that are current on the manufacturing floor.
What is the device history record (DHR)?
The DHR is the actual production records for a particular device. It should be able to show the
processes, tests, rework, etc. that the device went through from the beginning of its manufacture
through distribution.
What is the technical documentation file (TDF)?
The TDF contains all the relevant design data by means of which the product can be demonstrated to satisfy the essential safety requirements which are formulated in the Medical Device Directives. In the case of liability proceedings or a control procedure, it must be possible to turn over the relevant portion of this file. For this reason, the file must be compiled in a proper manner and must be kept for a period of 10years after the production of the last product.
The TDF must allow assessment of the conformity of the product with the requirements of the
Medical Device Directives.
What is the formula for the MTBF goal?
MTBF goal = (sample size)(test time)(2)/Χ²_(α;2r+2)
A clinical trial when is the ethical committee and competent authority needed?
When it’s to test the user evaluation then it’s just the ethical committee, but it’s both when its about the device performance.
What are the 3 different classification for how long a device can be implanted/used
Limited ≤ 24h
Prolonged >24h to 30d
Permanent >30d
Active Implantable Medical Device Directive (AIMDD)
- Implanted device with own power source
- can be implemented into the body or into a natural orifice
In vitro diagnostic medical device directive
- Any medical device that is reagent, reagent product, calibrator, control kit, instrument, or system intended to be used in vitro for the examination of samples derived from the human body.
Notified body
- Independence from the design, manufacture, or supply of the device
- Audit manufacturers
- Examines modifications
- Carry out CE verification
CE mark
- Added to products that complies with relevant essential product requirements
- It is the manufacturers job to apply the CE mark
Investigational New Drug (IND) Clinical trial
- Must be done under the supervision of a Human subjects Committee (ethical committee?)
Quality management system (QMS)
- QMS is a system that documents the policies, business processes, and procedures necessary for an organization to create and deliver its products or services to its customers, and therefore increase customer satisfaction through high product quality
