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ISO/IEC 27001 2022 Edition Compliance Project Special Service

ISO/IEC 27001 2022 Edition Compliance Project Special Service

Certification at a very reasonable price! Applicable for both transition audits and ongoing/renewal audits.

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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Product certification based on the Pharmaceuticals and Medical Devices Act.

Product certification based on the Pharmaceuticals and Medical Devices Act.

Before applying for certification, we offer a preliminary consultation (by appointment, up to approximately 2 hours)! Please feel free to contact us.

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.

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DQS Japan【MDR Latest Information】Conditions for Extension of MDD Transition Period

DQS Japan【MDR Latest Information】Conditions for Extension of MDD Transition Period

We will deliver the latest information on MDR. This time's theme is "What are the conditions for the extension of the MDD transition period?"

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

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European Medical Device Regulation (EU) 2017/745 (MDR)

European Medical Device Regulation (EU) 2017/745 (MDR)

Entry into further markets made possible! Approval of medical devices for sale or distribution in the European Economic Area.

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.

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[MDR Application Reception] European Medical Device Regulation (EU) 2017/745

[MDR Application Reception] European Medical Device Regulation (EU) 2017/745

Timely support for consultations in Japanese! We are currently accepting MDR applications within Japan.

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.

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How to Access the Japanese Market with Medical Devices <For Foreign Companies>

How to Access the Japanese Market with Medical Devices <For Foreign Companies>

Helping medical device manufacturers enter the Japanese market! Introducing the medical device approval (certification) steps.

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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MDSAP (Medical Device Single Audit Program for Canada, the United States, Brazil, and Australia)

MDSAP (Medical Device Single Audit Program for Canada, the United States, Brazil, and Australia)

To those considering entering the medical device market (Canada, the United States, Brazil, Australia)

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

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