Medical equipment approval industry record
Updated: July 2024, 3
We provide medical equipment, medical equipment, and other support services.
We have been working for a long time to support the production of articles, comprehensive ideas, starting new business, and supporting business operations.
Unfortunately, there is a lack of knowledge in the medical equipment industry, but we are not responsible for the production, enterprise, and administrative machinery operations of each department. Learn about the excellence and excellence of the industry.
Our general staff will make full use of our practical work, and our customers will provide all-round business support.
Ideas for expanding the medical equipment industry or those working in the medical equipment industry are unnecessary.
We provide the following business support:
- Medical equipment classification
- A summary of the approval and approval of the application.
- PMDA supports the approval of the certification machine
- Translation of the external test report for the test
- Certification book, STED production support
- QMS system construction support
We provide design and development support for the following businesses:
- Medical equipment classification
- Obtaining information on other companies' products and similar products
- PMDA supports the approval of the certification mechanism.
- External testing equipment
- Internal review support
- Support for the production of mutual records
We support the following businesses:
- Partial change, minor change of substitution request
- Support for production, modification, and supplementary materials
- QMS system construction guide
- Quality management process manual production, repair and revision guide
- Product usage instructions, packaging and labeling instructions
| Category | Message |
| tuning industry | It is very important to check in advance for approval and approval of medical equipment. We provide support for each category of business below. ・Confirmation of common name, fixed applicability ・Specific maintenance management medical equipment, repair category regulations ・Improvement category, post-distribution category settings ・Specifications for similar products from other companies |
| Language support business | We will prepare the materials and assist in the preparation of the medical equipment opening stage, the application preparation stage, and the PMDA's response time. ・Mean 对面应备备咨询 ・Medical equipment testing before the start of the test ・Learning before opening medical equipment ・Medical equipment demand and floor examination exam ・Medical equipment editing ・Medical equipment review ・Medical equipment application fee confirmation confirmation ・Medical equipment funding sufficiency application ・Easy study guide for confirmation before changing medical equipment ・Acceptance standard applicable sexual ease study ・Conjunctive language |
| Examination work | We hereby provide the following medical equipment certification and ratification application, examination and inspection of the place, examination report and translation. ・Electronic safety test (JIS T 0601-1/IEC 60601-1) ・Electromagnetic safety test (JIS T 0601-1-2/IEC 60601-1-2) ・Biological safety test (JIS T0993-1/ISO 10993-1) ・Home medical equipment examination JIS T 2001: Home optical cable management JIS T 2002: Household massage and finger replacement products JIS T 2003: Household electric appliances JIS T 2006: Household electromagnetic equipment JIS T 2007: Household permanent magnets |
| Certification application, ratification application support service | We provide medical services for approval, approval and support. ・Creation of certification book ・Production of approval application book ・Supplementary materials, production of STED ・Third-party approval mechanism, confirmation of amendments submitted by PMDA |
| Change-related support services | We provide support for the business of obtaining approval or ratification of medical equipment changes. ・Application for ratification of partial change ・Request for minor change ・Revision of supplementary materials and instruction manual ・Public law information |
