Medical Equipment Design & Mechanical Engineering Support

Service Overview

A Mechanical Design Partner For Medical Device Teams

Medical device companies carry the regulatory responsibility; what they often lack is mechanical design capacity at the moment a programme needs it. We supply that capacity: experienced mechanical engineers who work inside your templates, numbering, revision and approval workflow, and who produce the models, drawings, calculations and review material your team files in its design history file or technical documentation.

Our scope is the mechanical hardware of medical equipment — the cart, the enclosure, the frame, the fixture, the mechanism — designed with IEC 60601-1 mechanical-hazard requirements in mind (stability, moving parts, trapping zones, mobile-equipment transport) and with sheet-metal, moulding and machining manufacturability built in. Formal testing, risk-management ownership and regulatory submissions stay with you and your accredited partners.

• Medical carts, trolleys and mobile stands with tip-stability calculation and castor selection
• Sheet-metal and injection-moulded enclosures: draft, ribs, snap-fits, cleanability and ingress
• Mounting arms, brackets and frames for monitors, instruments and accessories
• Laboratory automation fixtures, test rigs and diagnostic instrument mechanics
• Design-transfer drawing packages, BOMs, tolerance stack-ups and FEA reports
• Legacy 2D-to-3D conversion and drawing updates for existing equipment (for the rights holder)

What this service is not: We are not ISO 13485 certified and not an FDA-registered establishment; we do not design implants, sterile disposables, drug-delivery or software-led devices, and we do not provide regulatory affairs services.

What We Need From You

Inputs We Work From

Send whatever you have. We list anything missing or ambiguous in a query sheet and agree it with you before modelling starts — nothing is assumed silently.

• Design inputs, user needs or a product requirements document
• Existing concepts, prototypes, reference equipment or legacy drawings
• Your design-control procedures, templates, numbering and revision scheme
• Applicable standards and the markets you target (for example IEC 60601-1 mechanical clauses)
• Interfaces: electronics, displays, cabling, accessories and consumables
• Preferred materials, finishes and manufacturing partners

What You Receive

Deliverables & File Formats

Design records

• Parametric native CAD in SolidWorks, Creo, Inventor, Solid Edge or NX
• Design review packs with options, rationale and open items
• Tolerance stack-ups and mechanical calculations as verification inputs

Risk and usability support

• Mechanical hazard inputs (pinch, stability, sharp edges, trapping) for your ISO 14971 risk file
• Ergonomic reach, force and access studies to support your IEC 62366 usability work
• FEA reports for stability, load and fatigue cases

Design transfer

• Manufacturing drawings to ASME Y14.5 or ISO GPS with your title block
• BOMs, assembly instructions and inspection-critical dimensions
• STEP, DXF and PDF supplier packs under your revision control

Native files in your platform and version (older versions on request), plus neutral STEP AP214/AP242, IGES, Parasolid, DXF and PDF as needed.