ドイツ品質システム認証 List of Products and Services

On March 15, 2023, the European Council passed a proposal by a majority vote to extend the validity period for high-risk devices already certified under the MDD until May 2027, and for medium-risk and low-risk devices until May 2028. The official announcement was published in the EU Official Journal on March 20, 2023. The extension of the deadline is conditional upon companies that have obtained current MDD certification completing their formal MDR applications to the Notified Body (N.B.) by May 26, 2024, and finalizing contracts as stipulated in MDR Annex VII section 4.3 with the N.B. by September 26, 2024. Only legacy devices under the MDD (MDCG 2021 25), meaning devices that were placed on the market after the application date of the MDR (May 26, 2021), are eligible to apply for the extension. DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications for the 70% of MDD-certified products that have not yet applied for MDR by 2024. Additionally, even for products already certified under the MDD, obtaining MDR certification will be necessary for design changes, so the resource shortage at the N.B. during the transition period is likely to continue.

• Quality assurance support systems and services

To those considering entering the medical device market (Canada, the United States, Brazil, Australia): Introducing MDSAP certification.

• Other quality control and hygiene measures

On February 16, 2023, the European Parliament passed a proposal by a majority vote to extend the validity period for high-risk devices that have already obtained MDD until May 2027, and for medium-risk and low-risk devices until May 2028. This decision will officially take effect with the publication of the EU Official Journal. The extension of the deadline is conditional upon companies that currently hold MDD certification completing their formal MDR applications to the Notified Body (N.B.) by May 26, 2024, and finalizing contracts as stipulated in MDR Annex VII section 4.3 with the N.B. by September 26, 2024. DQS is still accepting new MDR applications, but this decision is expected to prompt a rush of applications for products that account for 70% of MDD-certified products and have not yet applied for MDR by 2024. Additionally, even for products that have already obtained MDD, obtaining MDR will be required for design changes, so the resource shortage at the N.B. during the transition period is likely to continue. Please feel free to contact our representative for any further inquiries or second opinions regarding future actions.

• Other quality control and hygiene measures

In Japan, the Ministry of Health, Labour and Welfare (MHLW) regulates the manufacturing, sales, and distribution of medical devices. Medical device approval (certification) requires steps such as "application" and "QMS conformity assessment." Additionally, all application documents and technical documentation must be prepared in Japanese. The DQS Group can assist manufacturers of medical devices entering the Japanese market by dividing roles, so please feel free to contact us when needed. 【Medical Device Approval Steps (Partial)】 ■ Search for the general name of the medical device for which approval is sought, and examine the approval criteria and the status of existing devices in Japan to consider application methods and identify technical issues. ■ Select the applicant (MAH or D-MAH) and prepare the application. ■ Submit the application for medical device certification. ■ Conduct QMS conformity assessment. *For more details, please refer to the PDF materials or feel free to contact us.

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We provide product certification based on the Pharmaceuticals and Medical Devices Act. Our company has over 20 years of experience in medical devices and possesses a worldwide network of more than 200 experienced auditors. We also actively participate in standard committees and technical committees. Please download the catalog to view the list of certified product categories. 【Why choose DQS?】 ■ Over 20 years of experience in medical devices ■ Active participation in standard committees and technical committees ■ A worldwide network of more than 200 experienced auditors *For more details, please refer to the PDF materials or feel free to contact us.

• Other contract services

Medical devices for the European market are required to comply with the MDR (EU Regulation 2017/745) instead of the old MDD (EU Directive 93/42/EEC) as of May 26, 2021. Except for low-risk Class I devices, certification by a Notified Body (N.B.) is mandatory for Class Is, Im, Ir, Class IIa, IIb, and Class III medical devices. Our company acts as the Japanese contact point for the DQS Group, providing services for medical device certification based on Japan's Medical Device and In-Vitro Diagnostic Medical Device Act, as well as serving as the Japanese contact for DQS Medizinprodukte, the N.B. for MDR. Please feel free to consult us for more details. 【What DQS Japan Can Do for You】 ■ Provide bridging services between Japanese medical device manufacturers and DQS Medizinprodukte ■ Secure MDR auditors and Regulatory Affairs Managers residing in Japan, ensuring timely responses to inquiries in Japanese *For more details, please refer to the related links or feel free to contact us.

• Quality assurance support systems and services

As of May 26, 2021, the EU Regulation 2017/745 (MDR) has been established to replace the old EU directive on medical devices (93/42/EEC). In terms of content, the MDR differs significantly from the previous EU directives in many aspects. Among the important innovations are the expansion of the scope of application, the specification of minimum content for the creation and maintenance of technical documentation, and the tightening of requirements for clinical evaluation. Additionally, new classification rules have been introduced, including a new class classification for reusable surgical instruments, as well as devices that include software and nanomaterials. [Changes to Regulation (EU) 2017/745 for Medical Device Manufacturers (Partial)] ■ Expansion of the scope of application ■ Specification of minimum content for the creation and maintenance of technical documentation ■ Tightening of requirements for clinical evaluation ■ Introduction of new management procedures for high-risk medical devices ■ Appointment of a person responsible for regulatory compliance (PRRC) ■ Strengthening of requirements for post-market surveillance of medical devices *For more details, please refer to the related links or feel free to contact us.

• Quality assurance support systems and services

ISO 13485 is the international standard for medical device quality management systems. Companies that belong to one or more stages of the entire lifecycle of medical devices, from design and manufacturing to disposal, are eligible for certification. DQS Japan provides audit and registration services from the customer's perspective, keeping in mind that "there are as many systems as there are organizations," allowing management to determine whether the management system is truly beneficial within the organization. 【Benefits of Acquisition (Excerpt)】 ■ Competitive advantage in new market entry and overseas exports due to international standards ■ Increased trust from the market and customers, improved customer satisfaction ■ Contribution to employee awareness improvement and corporate culture enhancement ■ Standardization and clarification of work, increased sense of achievement in operations ■ Compliance with laws and regulations, enabling more accurate risk analysis *For more details, please refer to the PDF materials or feel free to contact us.

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As environmental destruction caused by corporate activities progresses, the depletion of resources has begun to be recognized as a real issue. To break this situation, the first edition of ISO 14001 was issued in 1996. Environmental protection is becoming an increasingly important role for all organizations, and environmental management system standards are becoming essential conditions for succeeding in the global market. Regarding environmental performance, we recommend activities that are commensurate with the corporate level, taking into account factors such as corporate value (corporate image) and collaboration with the community. [Benefits of Acquisition (Excerpt)] ■ Improvement of reliability in environmental management ■ Reduction of risks of environmental accidents and disasters in the workplace ■ Increased motivation of employees through workplace environment improvements ■ Enhanced business performance through workplace environment improvements ■ Improvement of corporate image by demonstrating the company's commitment to environmental management to the public and related companies *For more details, please refer to the PDF document or feel free to contact us.

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ISO 9001 is a widely recognized international standard for quality management systems. It aims to establish effective quality management systems and promote continuous improvement across various industries. Whether it is the quality of processes or the quality of final products, quality is a crucial aspect of corporate management and a key competitive factor against other companies. The principles of quality management help your company focus on purpose-driven, systematic management and the continuous improvement of performance. [Benefits of Acquisition] - Reduction in management costs and improvement in profit margins through increased productivity and reduced defect rates - Enhanced reliability through the introduction of globally recognized global standards, as well as reduced or waived second-party audits - Improved operational efficiency through standardization of operations - Clarification of responsibilities, authorities, and role distribution - Development of the organization through the activation of continuous improvement activities *For more details, please refer to the PDF materials or feel free to contact us.

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We would like to introduce our "ISO/IEC 27001 2022 Version Compliance Planning Special Service" that we are implementing. The international standard ISO/IEC 27001 (Information Security Management) was revised to its latest version in October 2022. In response to this revision, we are prepared to conduct audits compliant with the 2022 version promptly. As part of our special service period for the 2022 version, starting from January 2023 (end date undecided), we will offer reasonable special pricing for new certification registrations and changes in certification bodies. We encourage you to take this opportunity to consult with us. 【Features】 ■ Issuance of the registration certificate in as little as about 3 weeks ■ Audits based on the 2013 version are also possible ■ Audits conducted within the current audit cycle ■ Transition to the 2022 version must be completed by spring 2025 ■ Transition audits can be either continuation audits or renewal audits for the 2022 version *For more details, please refer to the PDF materials or feel free to contact us.

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We would like to inform you about the public seminar we will be conducting in 2023. The online seminar will be held via ZOOM. We welcome questions from everyone. To emphasize communication with the instructor, we limit the number of participants to approximately 12 to 16 per session. In the IATF16949-related seminars, we will conduct "IATF16949 Internal Auditor Seminar" and "IATF16949 Standard Detailed Explanation Seminar," among others. In the IATF16949 core tools-related seminars, we will hold "IATF16949 Standard Explanation & Core Tools Overview Seminar" and "APQP & PPAP Thorough Understanding Seminar," etc. [IATF16949-related Seminars] ■ IATF16949 Internal Auditor Seminar ■ IATF16949 Standard Detailed Explanation Seminar ■ IATF16949 Standard Explanation from the Perspective of Automobile Manufacturers Seminar ■ Automotive Industry Process Approach Explanation Seminar ■ VDA6.3 Explanation Seminar *For more details, please refer to the PDF document or feel free to contact us.

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