MEDICAL DEVICE EQUIPMENT QUALIFICATION – PRODUCTION & TEST EQUIPMENT

ProtomedLabs provides support to manufacturers to prepare and carry out medical device equipment qualification work. Qualification can guarantee that medical device equipments operate within specific known limits and that the output complies with predetermined requirements in order to improve overall product quality and reduce cost.  Medical device equipment qualification can be conducted on a wide range of machines used both in production room, QA and R&D laboratories. 

Medical device equipment qualification can be divided into 3 phases*:

  1. IQ – Installation Qualification: This work is carried out to demonstrate that the equipment installation complies with the suppliers’ installation drawings, specifications and instructions.  The IQ is conducted under protocol guidance at the client’s facility.  Existing suppliers’ qualification work can be integrated to develop the protocol and provide guidance for the qualification and establish Standard Operating Procedure (SOP). Equipment Installation Qualification considerations cover but are not limited to installation conditions, operating environment, calibration, preventative maintenance and schedules, design features, safety, instruction for use, document, technical drawings, and replacement parts.
  2. OQ – Operational Qualification:  This work is carried out to determine the equipment limitations and actions levels which may impact output results.  The OQ is conducted under protocol guidance at the client’s facility. Equipment operating parameters are assessed to determine the range which assures that the output meets all defined requirements under all anticipated operating conditions.  Understanding the equipment limits, avoids approaching worst case conditions during routine equipment operations. Equipment Operational Qualification considerations cover but are not limited to operating procedures, software, handling, training, control limits, process stability and capability, FMEA.
  3. PQ – Performance Qualification: This work is carried out to determine that the equipment consistently produces outputs which meet all predetermined process requirements during normal operating conditions.  The PQ validation is conducted under protocol guidance at the client’s facility.  Performance Qualification considerations cover but are not limited to product or test data acceptability, repeatability and stability requirements. 

 *Software qualification not included in these phases.

IQOQPQ work is conducted using a fully documented process to comply with most stringent medical device directives.  A full set of documents are prepared and delivered including reports with references to all protocols and results. All final reports are reviewed and approved by the qualified personnel per protocol requirements.  Our medical device equipment qualification services can be adapted to manufacturer’s regulatory environment and budget constraints.

DEVICE TESTING INTERNALIZATION SUPPORT

A fully integrated certified laboratory like ProtomedLabs, which can cover all the tests needed for cardiovascular medical devices, can be better suited to run comprehensive test programs and highly specific test activities to reduce overall R&D cost. On the other hand, internal integration of some testing activities can also accelerate R&D development cycles, reduces program failure risks, increases device confidence and reliability levels, improves regulatory path and optimizes validation time.  ProtomedLabs can help medical device manufacturers optimize cost by determining the proper balance between internalization and externalization of device testing activities for specific device projects.  By understanding short and long term organizational objectives, ProtomedLabs can provide expertise and develop a rationalized plan to internalize specific test activities.