STI applies a goal-driven QA process for ensuring that manufactured products and rendered services meet or exceed customer expectations. As a medical device manufacturer, STI is registered to EN ISO 13485 .

Scope:

  • Micro machining of metal components, including: laser processing, heat treatment and surface treatments;
  • Contract manufacturing of medical implants and surgical tools, intended for minimal invasive surgery, aesthetic surgical procedures, dental implants;
  • Assembly and packaging of medical devices and components in a controlled environment area.

Quality assurance, as practiced by STI, shifts the importance from quality inspection at the end of production towards responsible quality control throughout every aspect of production, thereby building quality assurance procedures into the process itself.

QA system

Quality assurance system

To ensure constant adequacy and effective compliance with EN ISO 13485  standards and all regulatory requirements, STI maintains a high standard of quality assurance system. Quality assurance verifies that any customer offering, new or updated, is produced and offered with the best possible materials, in the most comprehensive way, and according to the highest standards. STI verifies that employees have adequate skills and training for performing their tasks.

Quality controls

Strict quality controls verify that both products and processes meet specific requirements leading to dependable, satisfactory, and fiscally sound results. The quality control team identifies products that do not meet specified quality standards. When a problem is identified, any member of the quality control team may stop production temporarily.

Identification and traceability

Product lots or batches carry with them supporting identification markings and records throughout the process. The ability to identify each and every unit within a specific lot and all of its corresponding supporting records is a significant value to medical device companies that require individual product tractability, as well as the basis for many audit trails.

QA validation

Process validation

All processes at STI are validated. Validation proves that a process performs as specified using scientific and statistical principles.

Equipment qualification

STI performs equipment calibration and qualification according to approved programs and procedures (IQ / OQ / PQ), to satisfy both process and regulatory requirements.

Test method validation

STI performs TMV to ensure repeatability and reliability of testing methods. The goal is to capture as many sources of measurement variation as possible, so they can be assessed and understood. To capture repeatability errors, the same part is measured several times by each operator and by different operators. Each measurement cycle on an individual part includes the full set of operations required, as if the operator was testing different parts, including the complete handling, loading, and unloading of the part from the measurement system.

QA equipment

State of the art production and inspection equipment

STI uses several OGP SmartScope measuring systems for in-process and final dimensional inspections (tolerance ± 3 microns). These are fast, accurate floor model metrology systems offering a combination of hardware 3-axes performance, optical capability, and ease-of-use. These optical measuring systems streamline the inspection process with their automatic and programmable measuring abilities.

STI utilizes a large heat treatment furnace to ensure lot uniformity across a large batch.

STI also uses high speed LED/CCD Optical Micrometer to automatically measure the outer diameter and wall thickness of tube-like products. Such measuring system is fast, highly accurate and helps to reduce human errors.

Accreditation Certificate of Foreign Medical Device Manufacturer

In Japan, we obtained accreditation certificate of foreign medical device manufacturer by the Ministry of Health, Labor and Welfare (MHLW) under the examination of the Pharmaceuticals and Medical Devices Agency (PMDA); We were certified in 2017 after applying for renewal for the second time.

As a result of this renewal application, the validity period of the certificate is until February 8, 2022.