Engineering & DFM
Review drawings, materials, tolerances and assembly requirements with your engineers. Document manufacturability risks and proposed changes for your team's review through its change-control process.
MEDICAL DEVICE INDUSTRIALISATION IN CHINA
From existing design
to documented production.
BSense works alongside your medical-device engineering, quality and supply-chain teams to adapt existing designs for manufacturing and coordinate process selection, tooling trials and production in China.
COMPLEMENT YOUR ORGANIZATION
Use BSense where
capability is required.
Retain your internal engineering and quality organisation. Engage BSense for a defined DFM or design-transfer task, supplier qualification, production trials or wider manufacturing coordination. The scope and responsibilities are agreed around your device and its requirements.
Your teamDesign authority
Quality requirements
Quality requirements
Shared requirementsDocumented feedback
BSenseEngineering coordination
Manufacturing execution
Manufacturing execution
DFM & design transfer → Process & supplier selection → Tooling trials → Pilot builds → Production control
MEDICAL-DEVICE CAPABILITY
Technical support connected
to production reality.
Prototyping & Industrialization
Distinguish design-verification prototypes from trials on the intended production processes and equipment. Coordinate representative builds, measurements and issue closure before the next agreed stage.
Tooling
Coordinate tooling trials and adjustments against component and assembly requirements. Review first articles, critical dimensions and acceptance criteria with your quality and engineering teams.
Supplier Qualification
Identification, assessment and coordination of manufacturing partners appropriate to each program's technical and quality requirements.
Manufacturing Management
Production planning, supplier coordination, issue resolution and operational visibility from the ground in Dongguan.
Quality Control & Inspection
Program-specific inspection, documentation, non-conformance handling and release controls agreed with the customer.
QUALITY THROUGH THE PROGRAM
Control agreed.
Evidence documented.
Quality activity is defined around the product, process, risk and customer requirements. BSense coordinates the agreed controls and keeps responsibilities visible throughout execution.
A CLEAR RECORD AT EVERY GATEDefine. Inspect.
Define. Inspect.
Document. Review.
- Agreed inspection criteria
- Recorded measurements
- Issue and action tracking
- Release status visibility
Supplier qualification
Capability, process and program fit assessed before production responsibility is assigned.
First article inspection
Initial parts checked against agreed requirements before production progression.
Incoming & in-process inspection
Controls positioned where they can identify variation before value is added downstream.
Final inspection
Finished output reviewed against the agreed inspection and documentation plan.
Non-conformance & corrective action
Issues documented, contained and followed through practical corrective action.
Documentation & shipment approval
Required records assembled and release status made clear before shipment.
Certification clarity
Required certifications are verified for the proposed manufacturing site and scope. Supplier certifications do not imply certification of BSense. The engagement defines production, quality and release responsibilities; manufacturing coordination is not a claim of product regulatory approval.
MANUFACTURING NETWORK
Processes selected
around the program.
BSense identifies, qualifies, coordinates and controls manufacturing partners appropriate to the design, production process, quality requirements and expected volume.
YOUR PROGRAMDesign · Volume · Quality
Form & toolingMake & assembleInspect & release
CNC machiningInjection moldingDie castingSheet metalExtrusionSiliconeElectronics / PCBASurface finishingAssemblyPackaging
PROJECT IN PRACTICE
Handheld medical-device enclosure
From existing CAD
to injection-molded production.
The project began with supplied 2D drawings and 3D models. Further engineering was needed to make the components suitable for injection molding and straightforward to assemble.
- The manufacturing challenge
- Adapt the existing component designs for the molding process while making the parts easier to assemble together.
- BSense’s contribution
- Rework the designs for manufacturability and assembly, produce prototypes, develop the injection molds and carry the project through to production of the component sets.
- The outcome
- The project moved from supplied drawings and CAD through DFM redesign, prototyping and tooling into production.
- 01Supplied drawings
& CAD models - 02DFM & assembly
redesign - 03Prototypes
- 04Injection molds
- 05Production
Interfaces, tolerances and assembly reviewed together.
Detailed drawings, CAD files and production volumes are not published. Project-specific evidence can be discussed subject to confidentiality. Visuals illustrate device types and production activities.
EVIDENCE, NOT ASSUMPTIONS
Qualification-ready
information.
Relevant project evidence, inspection capability, manufacturing processes and supplier documentation can be reviewed for a specific opportunity, subject to customer confidentiality and authorization.
Agree the evidence required
Define the trial reports, inspection records and issue-resolution evidence needed for your qualification process. Any client references are subject to availability and permission.
Program-specific qualification
Capabilities and certification status are confirmed for the partners proposed to the program.
Named delivery team
Relevant engineering, manufacturing, operations and quality responsibilities are identified during qualification.
DISCUSS YOUR MANUFACTURING REQUIREMENTS
Plan the next manufacturing step.
Share the current stage, technical constraint, expected volume and quality requirements. We will identify where BSense can complement your organization.
NORTH AMERICAN COMMERCIAL SUPPORTbsense@bsense-group.comNorth American commercial support · Direct Dongguan coordination