EU MDR QMS
EU Quality Management System Certificate
Redacted public preview issued by TÜV SÜD Product Service GmbH under Regulation (EU) 2017/745, Annex IX Chapter I.
Package states valid until 2030-09-02Reusable dual chamber pen systems for global peptide projects
For peptide, lyophilized biologic and pharmaceutical development programs.
A reusable 4 mL pen platform, matched dual chamber cartridge, needle options and OEM packaging through one coordinated global B2B project pathway.
Up to 4 mL format*0.01 mL increment*OEM and ODM available
Built for global drug-device projectsTechnical screening starts with the formulation, cartridge, preparation sequence and dose program—not a country label.
Peptide projectsExplore where separated storage and point-of-use preparation may be relevant.
Lyophilized formulationsTranslate dry-powder and diluent requirements into device-screening inputs.
Pharma, biotech and CDMOCoordinate pen, cartridge, needle and packaging requirements.
Global OEM programsPlan color, branding, packaging and project-specific documentation.
Build around the complete delivery system
Start with the reusable pen platform, then confirm cartridge geometry, needle selection and packaging requirements for the intended market and filling process.
Reusable dual chamber pen
White standard configuration with color and branding options. Dose range and performance are verified against the selected cartridge.
Review the pen platform →
Dual chamber cartridges
Glass cartridge sourcing coordinated with the device. Bypass, stopper and interface geometry are matched before quotation.
Review cartridge fit →
Pen needle options
Compatible single-use needle options are selected according to the device, target market and project requirements.
Ask about needle options →
Packaging solutions
Custom artwork, carton structures, trays and patient-facing materials can be quoted as part of the OEM project.
Plan branded packaging →* Reference specifications and commercial terms come from the supplied project package. Final performance, compatibility, availability and timelines are confirmed in the quotation for the ordered configuration.
Separate during storage and combine at the point of use
The architecture is intended for projects where a dry component and liquid component must be kept apart until preparation. The exact mixing sequence and delivered dose require configuration-specific validation.
1
Define the formulation requirementsShare fill volume, dose range, viscosity and target market.
2
Match the device and cartridgeConfirm dimensions, interfaces, stoppers and compatibility criteria.
3
Verify the selected configurationReview samples, documentation and project-specific test requirements.
The image is a project reference example. Pharmaceutical formulation, filling and compatibility validation are not supplied by this webpage.
Move from requirements to a qualified order
Each stage creates a concrete decision point for procurement, technical and regulatory teams. Project terms remain subject to sample approval and written confirmation.
Step 01
Project brief
Define device, cartridge, target market, volume, color, logo and documentation needs.
Step 02
Sample review
Review physical samples and confirm the intended device configuration and finish.
Step 03
Technical confirmation
Align drawings, material information, compatibility checks and required evidence.
Step 04
Production order
Approve commercial terms, artwork, batch requirements and release documentation.
1,000 unitsReference MOQ
3 daysReference sample timing
15–20 daysReference production timing
Start an OEM review →
Inside the manufacturing environment
The supplied manufacturing photographs show moulding equipment, automated component handling, inspection systems and controlled production areas. Quality-system scope and platform applicability are confirmed for each order.
15,000 m²Reported manufacturing floor area
350Reported team size
100M / yearReported installed capacity
130+Reported patents and utility models
Manufacturing-site figures are from the supplied REVADUO project package and should be reconfirmed in commercial documentation.
Explore the factory environment →Certificate scope stated carefully
The public previews are redacted copies supplied in the project package. They support discussion of the manufacturing site; they are not presented as certificates held directly by REVADUO.
MDSAP · ISO 13485
Pen injector quality system scope
The supplied redacted copy lists design and development, production and distribution of pen injector and disposable pen injector.
Package states valid until 2029-02-11Document pathway: qualified buyers can request applicable certificate copies, dimensional information and project-specific documentation. Unredacted confidential evidence is not published or automatically sent from this site.
Screen the project before the first call
Clear boundaries help technical buyers decide what information to share and what must still be verified.
Does REVADUO supply pharmaceutical formulations?
No. The website presents device and component sourcing for pens, cartridges, needles and packaging. Drug formulation, filling and pharmaceutical services are outside the stated scope.
Can the pen, cartridge and needle be ordered together?
They can be included in one sourcing discussion, but compatibility and availability must be confirmed for each selected component and target market.
Are 4 mL and 0.01 mL guaranteed for every order?
No. They are reference specifications from the supplied project package. Dose range, accuracy, cartridge volume and performance require written confirmation for the ordered configuration.
What can be customized?
Color finish, logo application and secondary packaging can be discussed. Final options, minimum order quantities and artwork requirements are confirmed in the quotation.
Share the requirements that determine fit
Include the product of interest, expected quantity, destination market and the technical information already available. The page prepares an email; it does not transmit or store form data.