2. What are SMP GmbH and SMP Laboratories Japan?
We, SMP GmbH [i] and SMP Laboratories Japan Co., Ltd. [ii] , mainly provide verification: verification and validation: validation services and related research and development for medical devices and medical device regeneration processing devices. I have a livelihood.
SMP GmbH, a German corporation, is a private independent inspection agency accredited [v] by ISO 9001 quality management system [iii] , ISO / IEC 17025 laboratory and calibration body [iv].
Its Japanese subsidiary, SMP Laboratories Japan Co., Ltd., provides contact services for testing at German laboratories, technology transfer for testing in Japan, and advice and consulting to medical institutions and medical-related companies. I am going.
Medical devices in Japan, the United States, etc. are "Approval" by public institutions and can be distributed as medical devices.
On the other hand, in Europe, the notification body / Notified Body [vi] (a private body that can perform conformity assessment certified by the European Commission) examines the basic requirements, technical documents and the construction and maintenance of a "quality management system". Obtain "Certificate" for products and services that meet the above requirements.
The quality management system for basic requirements and technical documents related to medical device certification in Europe is ISO13485. It conforms to the quality management system [vii] related to medical device manufacturing, and is a basic requirement and a minimum requirement. That is, in some countries, additional requirements must be met.
Regarding the certification of medical devices, it is said that the standards of German requirements are high even in Europe, but there are also requirements unique to each country, so confirmation is required.
ISO17664 Healthcare Product Processing Revised in 2017 Information [viii] that medical device manufacturers should provide regarding medical device regeneration processing has been revised to invasively or directly or indirectly contact patients (Class IIa and above). Medical equipment) Regeneration processing process for medical equipment that is used repeatedly on the premise of
1) Pretreatment after clinical use
2) Preparation before cleaning
3) Cleaning
4) Disinfection
5) Dry
6) Inspection, maintenance and functional testing
7) Packaging
8) Sterilization
9) Storage
10) Supply
Detailed information is required.
In particular, "cleaning" is positioned in the preface of the requirement as the first step and most important for the safe use of clinically used medical devices. Unless contaminants, blood, tissues, microorganisms, cleaning agents, lubricants, etc. remain on the outer and inner surfaces (chambers) of medical devices, problems with subsequent disinfection and sterilization processes and medical devices It points out that the normal functioning of the can be compromised.
Therefore, the "medical device manufacturer" has "responsibility to guarantee the regenerative processing" in the design of the medical device, so that the validated (validation) process that can be used by the business operator (= medical institution) can be carried out. You are required to provide information and support.
Furthermore, according to the European Medical Device Regulation [x] , which will come into effect from 2020 from the European Medical Device Directive [ix] , the objective data for guaranteeing these regeneration processes is ISO / IEC. 17025 Only approved by medical device manufacturers that are accredited by laboratories and calibration laboratories.
In addition, for medical devices of class IIa or higher, which are classified according to the type of safety risk, purpose, application, etc. in the use of medical devices, even medical device manufacturers that have acquired ISO / IEC 17025 Test data is not accepted, and you cannot even apply unless you objectively show that you meet various requirements by conducting tests by an externally accredited Independent Accreted Testing Laboratory. It will be [xi] .
At SMP GmbH in Germany, we are familiar with the requirements of each country such as ISO, Europe, the United States, and Asian and Oceanian countries, and we prepare test plans, conduct tests, and meet the requirements for certification that meet these requirements. As an independent testing institute, we provide a certificate for the results along with the test data.
As mentioned above, we at SMP Laboratories Japan Co., Ltd. provide contact services for various tests to SMP GmbH in Germany, as well as advice and consulting for tests conducted at SMP GmbH, and some test technology transfer services. I am doing.
In addition, SMP Laboratories Japan Co., Ltd. provides education and training on quality management systems related to medical devices, especially "internal management".
These methods we provide are aimed at preventing quality management systems from becoming mere ghosts.
Not a little experience, such as the procedure manual created with great effort does not work as expected, PDCA does not turn due to miscommunication between the person in charge of each appointed section and the person in charge of the field, the business operator, and the manager. Many people have done it.
SMP Laboratories Japan Co., Ltd. provides education and training centered on sustainable "management" to top management, managers and practitioners appointed as heads of each section. ..
[i] “Über SMP GmbH”. SMP GmbH. Https://smp.smpgmbh.com/geschichte.html
[ii] “Company Profile”. SMP Laboratories Japan Co., Ltd. https://www.smplabjapan.com/blank-3
[iii] “ISO 9001: 2015 Quality management systems --Requirements”. International Organization for Standardization. Https://www.iso.org/standard/62085.html
[iv] “ISO / IEC 17025 General requirements for the competence of testing and calibration laboratories”. International Organization for Standardization. Https://www.iso.org/standard/66912.html
[v] “Qualitätsmanagement ISO 9001 | DIN EN ISO 17025, DEKRA Zertifikat”. SMP GmbH, Qualitätsmanagement. Https://smp.smpgmbh.com/qualitaetsmanagement.html
[vi] “Notified bodies, What the notified bodies do”. Notified body, The single market and standards, European commission. Https://ec.europa.eu/growth/single-market/goods/building-blocks/notified- bodies_en
[vii] “ISO 13485: 2016 Medical devices --Quality management systems --Requirements for regulatory purposes”. International Organization for Standardization. Https://www.iso.org/standard/59752.html
[viii] “ISO 17664: 2017 Processing of health care products --Information to be provided by the medical device manufacturer for the processing of medical devices”. International Organization for Standardization. Https://www.iso.org/standard/62952 .html
[ix] “Medical device Directive 93/42 / EEC”. Medical devices, The single market and standards, Internal Market, Industry, Entrepreneurship and SMEs, European commission. Https://ec.europa.eu/growth/single-market / european-standards / harmonised-standards / medical-devices_en
[x] “Regulation (EU) 2017/745, The new Regulations on medical devices, Regulatory framework”, Regulatory framework, Medical devices, Sectors, Internal Market, Industry, Entrepreneurship and SMEs, European commission. Https://ec.europa .eu / growth / sectors / medical-devices / regulation-framework_en
[xi] The European parliament and the council of the European union, Regulation (EU) 2017/745 of The European parliament and the council of the European union of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation ( EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC. 2017, p8 (60).