Medical, Dental & Healthcare
Medical & diagnostic device assembly, kitting and launch support.
Bring the product requirements. RELY can help turn them into a build, a kit and a documented launch. RELY Contract Manufacturing supports medical, diagnostic, dental and healthcare product teams with assembly, component sourcing, kitting, packaging and inspection to approved requirements. Three historical programs show the work: a test-kit launch, an assembly transfer that grew into seven product lines, and a scientist-built device turned into documented assembly another team could run.
Mask program · assembly, cleaning and kitting
At a glance
From product requirements to a documented build.
RELY helps teams turn product knowledge into work another trained operator can follow: process observation, visual instructions, defined inspection points and an agreed pilot. The scope can include assembly, kitting, packaging, inspection and rework, with documentation and traceability matched to the program.
The examples below cover three different needs: launching a kit (Case Study No. 14), moving an established assembly process (No. 13) and moving repeatable assembly out of scientists’ hands (No. 22).
- Serves
- Medical, diagnostic, dental and healthcare product companies and their suppliers
- Work
- Assembly, component sourcing, kitting and packaging, inspection and rework
- Quality system
- ISO 9001:2015, Amtivo certificate 263741, valid through March 19, 2027. Certificate (PDF)
- Release
- Stays with the customer unless a specific written agreement says otherwise
- Location
- 52,000 sq ft facility in Menomonee Falls, Wisconsin
Case Study No. 14 · COVID-19 Test Kit Launch · 2022
The test was ready for validation. The kit still had to be built.
A molecular diagnostics company needed saliva self-collection kits for clinical validation of a COVID-19 test. The customer owned the science and two custom components. RELY helped define the kit materials and packaging, managed sourcing and printing, documented the build and assembled the pre-production lots for investigational use.
- 6,005
- Kits shipped: three documented 2,000-kit validation lots plus five PPAP samples
- 9 days
- From first article to the first 2,000-kit lot
- 9
- Inspection points in each kit’s assembly process
- What RELY owned
- Kit-material and packaging selection against the customer’s specification, sourcing or printing nine of eleven BOM lines, print coordination, visual work instructions, assembly, inspection and lot documentation.
- Build controls
- Nineteen documented assembly and inspection steps, ten physical pieces per kit with count verification, and checks covering print quality and component condition before sealing.
- Launch records
- The case reports full PPAP, including a supplier survey, quality agreement, first article and a completed build record for every lot. Each shipment carried a certificate of conformance with component lot numbers; sub-lots traced back to the parent lot.
- Delivery sequence
- The three 2,000-kit lots were dated April 28, June 2 and September 2, 2022. The nine-day result describes first article to the first lot, not all three lots.
Source: RELY Case Study No. 14, COVID-19 Test Kit Launch. Pre-production kits for investigational use in a 2022 program. These are historical program results, not standard lead times or evidence of regulatory clearance or clinical outcomes.
Why healthcare product teams call RELY
Controlled work that has outgrown the team doing it.
01 · Assembly capacity
The parts are ready. Assembly is at capacity.
Molding or component production can keep up, but assembly, cleaning, kitting or packout compete for the remaining people and floor space. See the mask assembly case
First moveObserve the current process, document the method and define the operation to transfer.
02 · Technical staff on the build
Technical staff are still tied up in repeatable assembly.
Experienced technical staff are assembling units while repeatable production work competes with development, engineering and other higher-value technical work. See the documented-build case
First moveObserve the build, document the method and scope a pilot that another trained operator can follow.
03 · Kits and packaging
The build is only part of the work.
Accessory kits, labeling and packaging compete for the same people and space as the core operation.
First moveDefine the BOM, packaging requirements, identity checks and release records as part of the program.
04 · Inspection backlog
Product waits on inspectors, not criteria.
Incoming or in-process inspection has fallen behind, and material is waiting on people rather than on a decision.
First moveRun inspection to your written criteria with records you can audit.
05 · Supplier issue
Components failed incoming inspection.
Suspect components need to be sorted and documented without losing lot traceability.
First moveSort, segregate and report by lot, with disposition left to you.
06 · Legacy products
Older products still have to ship.
Replacement parts and mature products still need supply after engineering has moved on to the next design.
First moveKeep them building to the approved documentation.
Where RELY fits
Defined operations, documented end to end.
Assembly and subassembly to your documents.
Mechanical and electromechanical assemblies built to approved documentation, with visual instructions, checks at the station and revision control.
Explore contract assembly and subassembly → Kitting & packagingKits sourced, built and verified.
Kit materials and packaging reviewed against your specification, then built to the approved BOM with count, label and lot checks before release.
Explore kitting and contract packaging → Inspection, testing & reworkInspection and rework to your criteria.
Visual, dimensional, functional and electrical checks to your criteria, and rework only under an approved instruction.
Explore inspection, testing and rework → Value-added manufacturingLabeling and repackaging.
Approved label and packaging changes on existing inventory, with counts reconciled and records kept.
Explore value-added services →
Case Study No. 13 · Medical Mask Assembly Transfer · 2021-2022
Moved in from out of state. Running in under four weeks.
A Wisconsin injection molder wanted its mask assembly transferred in from out of state to sit closer to its molding operation. Before committing to the move, it needed real numbers on labor content and throughput. RELY time-studied the assembly work so the labor requirement was known before the move, then had production running at RELY in under four weeks from go-ahead.
The customer shipped molded components to RELY, where the team assembled, cleaned and kitted small, medium and large masks under RELY’s Good Manufacturing Practice (GMP) policies for that program. More than 102,000 masks were individually bagged and packed for shipment.
- Start-up
- Production at RELY in under four weeks from go-ahead, after a pre-move time study
- Masks assembled
- 104,609, April 2021 to May 2022, in three sizes
- Peak month
- 17,375 masks in September 2021
- Components
- 307,347 molded components assembled into masks
One fast start became seven product lines. Beginning in May 2021, the same customer moved six more product lines to RELY: molded parts that needed assembly, kitting or packout. From April 2021 to August 2022, RELY built 210,689 units across the seven lines. That total includes masks; it is not a mask total.
Source: RELY Case Study No. 13 and RELY ERP records. Historical program, 2021 to 2022; images are from that program. Volumes and GMP practices describe this specific program; new work is scoped to its own requirements.
Case Study No. 22 · Diagnostic Device Assembly Launch · 2022
Built by scientists. Turned into a process RELY could run.
A medical diagnostics developer relied on its scientists to assemble cartridges by hand in 1,000-unit lab lots, and demand was arriving faster than the lab could build. RELY documented the work in 18 visual assembly and inspection steps, joined a three-day joint build at the customer’s lab eight weeks after the first process walk, and later assembled 300 cartridges at RELY.
01
Observe the actual build.
RELY worked alongside the builds at the customer’s lab and recorded every station with video and photographs.
02
Document the assembly.
18 visual assembly and inspection steps captured tools, parts, PPE and correct-versus-incorrect examples, then were revised with the customer.
03
Put inspection inside the sequence.
Three critical-to-quality inspection gates sit where defects were easiest to introduce and hardest to catch downstream.
04
Build together.
Eight weeks after the first process walk, RELY operators joined a three-day joint build at the customer’s lab. Combined output: 1,100 cartridges.
05
Improve the workstations.
RELY advised on press assistance, magnified lighting, counting tools and supplies to support the process.
06
Assemble at RELY.
In fall 2022, 300 cartridges were assembled at RELY, with each serialized cartridge matched to its bag before the final heat seal.
Source: RELY Case Study No. 22 and RELY project records, February through fall 2022. The 1,100 cartridges are combined output from the joint build with the customer’s team; the 300 cartridges were assembled at RELY. Historical program; controls for a new scope are defined against its own requirements.
From Quote to Scale
Crawl, walk, run. Prove the method before volume.
Crawl: walk the build
Review the build sheet, product requirements, current method, handling risks and inspection points.
Crawl: document the method
Define visual instructions, materials, tools, correct and incorrect examples, and customer-approved acceptance criteria.
Walk: evaluate a pilot
Agree what the pilot must demonstrate, record results and confirm process, training and checks.
Run: transfer the defined scope
Expand the approved operation with agreed volumes, material flow, reporting and change control.
Product approvals, acceptance criteria and release stay with the product owner. RELY performs the contracted operation, segregates nonconforming material for your disposition and does not change a process, material or revision without your approval.
Questions healthcare buyers ask
Short answers. Full answers in the FAQ.
Does RELY have medical-specific case studies?
Yes. Case Study No. 14 documents a 2022 saliva test-kit launch: 6,005 kits shipped in three 2,000-kit validation lots plus five PPAP samples. Case Study No. 13 documents a 2021-2022 mask assembly transfer: production at RELY in under four weeks from go-ahead and 104,609 masks assembled in three sizes under RELY’s GMP policies for that program, with the relationship growing to seven product lines. Case Study No. 22 documents how a scientist-built diagnostic cartridge assembly became 18 documented steps another team could run. These examples cover different manufacturing needs.
See the test-kit launchCan RELY source components and assemble a medical or diagnostic kit?
Yes, subject to the program’s requirements. In Case Study No. 14, RELY sourced or printed nine of eleven BOM lines, documented the build, assembled and inspected the kits, and supplied shipment records with component lot numbers. A new kit starts with the approved BOM, material and packaging requirements, acceptance criteria and release responsibilities. Cleanroom, sterility and other special requirements must be reviewed during scoping.
Full answer: verifying kit contentsHas RELY assembled, cleaned and kitted products under GMP policies?
Yes, in one historical program. In Case Study No. 13, RELY assembled, cleaned and kitted masks in small, medium and large sizes under RELY’s Good Manufacturing Practice policies for that 2021-2022 program. The work included a pre-move time study, individual bagging and packout for shipment. For new work, the required procedures, cleaning requirements, documentation and release responsibilities are agreed during scoping.
Read Case Study No. 13Can RELY help document a build that currently depends on our scientists or engineers?
Yes. In Case Study No. 22, RELY observed the builds at the customer’s lab, documented the assembly in 18 visual assembly and inspection steps with three inspection gates, joined a joint build eight weeks after the first process walk and later assembled 300 cartridges at RELY. A new program starts by reviewing the actual operation, acceptance criteria and documentation requirements, then agreeing the scope and pilot.
Read Case Study No. 22What traceability can RELY provide?
Traceability is defined for the program. In Case Study No. 14, each shipment carried a certificate of conformance with component lot numbers, and sub-lots traced to their parent lot. Case Study No. 22 included matching each serialized cartridge to its bag before the final seal. Your required records and identification levels are agreed during scoping.
Full answer: lot traceabilityIs RELY ISO 13485 certified?
RELY’s quality management system is certified to ISO 9001:2015 for contract manufacturing and assembly. RELY does not claim ISO 13485 certification. If your program requires an ISO 13485 certified supplier for the work, say so at the start so both teams can confirm fit before investing time.
Full answer: RELY’s certificationWho releases the finished product?
You do. RELY performs the defined operation to your requirements and records the results. Product design, acceptance criteria and release authority stay with the customer unless a specific written agreement says otherwise.
Full answer: handling nonconformanceCan we start with a pilot?
Yes. A pilot can confirm the method, cycle time, checks, documentation, material flow, testing and training requirements. Both teams agree beforehand on what the pilot must demonstrate and who approves the results.
Full answer: starting with a pilotBring us the kit or assembly work your team needs to move forward.
Start with your parts list or build sheet, target volumes and timing, or tell us about the build your technical team still owns. RELY can review material and packaging choices, define the assembly, cleaning and kitting scope, and map the records your quality team needs. A sample review or practical pilot comes before any commitment to volume.
- Parts list or build sheet
- Target volumes
- Timing
- Packaging requirements
- Records you need
General: 262.276.0050 · info@relycm.com