Here you can find all the products that MedicalMountains offers to support the medical technology industry.
Step-by-step guide EU-MDR Class Ir
In tabular form, the current requirements for class I medical devices are compared to the new specific EU MDR guidelines for “reusable surgical instruments” class Ir. In this way, companies can work through the relevant aspects in logical and chronological order, ie step by step. In addition, there are three comprehensive checklists on safety and performance requirements, technical documentation and post-marketing technical documentation.
All medical device companies whose products are covered by the MDR 2017/745 can order the guide from MedicalMountains by e-mail.
Please submit the signed confidentiality declaration. Your investment:
- regular 320,00 EUR (plus VAT)
- for TechnologyMountains members 290,00 EUR (plus VAT)
- Passive members of the MedicalMountains-ExpertTable EU-MDR receive an additional 20% discount.
SME Guide to Standardized Cleaning of Surgical Instruments
The guide developed under CleanMed shows a standardized approach for small and medium-sized enterprises (SMEs). It can be used as a basis for own validation of cleaning processes.
The focus is on the product cleanliness of non-sterile reusable surgical instruments on delivery. However, many aspects of the guideline are also applicable to other medical devices made from metallic materials and implants.
Proof of chemical and biological cleanliness in the framework of project development was made in accordance with the principles of integrated safety and taking into account the generally accepted state of the art.
The guideline is structured chronologically, designed in a modular system and leads through six necessary process steps:
More information can be found here.
The SME Guide can be ordered by e-mail. The delivery time is 4-6 weeks.
- 998,00 EUR (plus VAT)
The package contains:
1 printed guide
1 box with 3 final cleaned, welded test specimens
1 USB stick with supplementary documents
- Further specimens can be purchased if required.