Mi3

What Mi3 does

Mi3 Limited is a UK-based contract medical device design, development, and manufacturing company founded in 2006 and headquartered in Blackburn, Lancashire. The company delivers end-to-end services spanning concept consultation, SolidWorks CAD-based design, regulatory strategy, ISO 13485-compliant manufacturing, and validated production, operating from a single site that houses ISO Class 7 cleanroom facilities and a Controlled Manufacturing Environment (CME). Core manufacturing capabilities include thermoplastic injection moulding, medical tubing extrusion with laser OD/ID measurement, ultrasonic welding, validated Gamma and EO sterilisation, sterile packaging, prototyping/3D printing, and complex electromechanical assembly.

The company serves enterprise customers in three primary verticals: medical device OEMs, in vitro diagnostics (IVD) manufacturers, and biotech equipment firms, alongside medical product companies requiring virtual manufacturing and own-brand labelling support. Named enterprise clients include Medela AG and Cantel (UK) Ltd. Mi3 holds MDSAP certification (ISO 13485:2016) since July 2018, enabling single-audit compliance across Australia, Brazil, Canada, Japan, and the US, and supports regulatory pathways for UK, EU MDR/IVDR, and international markets.

Mi3 is a privately held UK limited company (Companies House #05778266) with 51-100 employees. The company's corporate email domain (karlstorz.com) indicates ownership or controlled affiliation with Karl Storz, a major medical technology group, positioning Mi3 as an operating unit within a larger international medtech organisation. Revenue is generated through project-based, quote-based contracts with multi-year engagements; no pricing is publicly disclosed and no external funding rounds are recorded. The go-to-market motion is direct B2B sales supported by content-led thought leadership via a resource centre of whitepapers and regulatory guides.

Name

Mi3

Legal name

Mi3 Limited

Website

https://mi-3.co.uk

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

51–100 employees

Short description

Mi3 is a UK-based contract medical device design, development, and manufacturing company that provides end-to-end services from CAD design through ISO 13485/MDSAP-certified cleanroom production for medical device OEMs, IVD manufacturers, and biotech firms.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Medical & Life Sciences Injection Molding (Devices, Diagnostics, Cleanroom) (IMANAFAC)

akta.pro secondary industries

Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers) (HLAHANAB), Sterilization Consumables & Packaging (Wraps, Pouches, Indicators, Trays/Containers) (HLAHANAC), Medical & Dental 3D Printing Services (patient-specific devices, dental labs) (IMAAADAG), Sterile & Aseptic Medical Packaging (Pouches, Wraps, Sterile Barriers) (IMALAIAB)

Keywords

• Medical device manufacturing
• Contract manufacturing
• Medical device design
• IVD development
• Cleanroom manufacturing

Headquarters

HQ city

Blackburn

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Contract Manufacturing: Manufacturing and assembly of medical devices including injection moulding, extrusion, ultrasonic welding, and packaging services under ISO Class 7 cleanroom and CME environments. Revenue generated through production contracts for medical device components and assemblies.
2. Design & Development Services: Medical device product development services including concept design, CAD modeling, tool design, prototyping, and design transfer to manufacturing. Billed through project-based consulting and design service contracts.
3. Regulatory Compliance Services: End-to-end regulatory services and consultancy throughout the device lifecycle, from regulatory strategy at design outset through ongoing product maintenance, including Technical File services and virtual manufacturer support.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Mi3 designs, develops, and contract-manufactures medical devices, in-vitro diagnostics (IVD), and biotech equipment end-to-end, from concept and regulatory strategy through ISO Class 7 cleanroom production, packaging, and sterilisation. Services include CAD-based device design, regulatory compliance consulting, thermoplastic injection moulding, cleanroom extrusion, ultrasonic welding, rapid 3D prototyping, validated sterilisation, and packaging under ISO 13485:2016 via MDSAP.

Product overview

Mi3 is a contract medical device design, development, and manufacturing company offering end-to-end services for medical devices, IVDs, and biotech products. The company operates a platform of integrated services including Device Design & Development (using SolidWorks CAD software), Regulatory Compliance Services, and Contract Manufacturing capabilities. Manufacturing services encompass ISO Class 7 Cleanroom Manufacture & Assembly, Packaging, Injection Moulding, Extrusion, Ultrasonic Welding, Prototyping/3D Printing, Sterilisation, and CME Product Assembly. Mi3 serves three market sectors: Medical Devices, In Vitro Diagnostics, and Biotech, providing services from initial concept consultation through to validated production ready for market distribution.

Differentiator

Problem solved

Functional benefit

Products and services

• Device Design & Development Medical device product development following structured key phases from concept to design transfer to manufacturing, using SolidWorks CAD software to translate product ideas into comprehensive CAD image files for validated marketable devices.
• Regulatory Compliance Services End-to-end regulatory services and consultancy throughout the medical device lifecycle, from creation of Regulatory Strategy at the outset of design and development, through to ongoing product maintenance, including Technical File services and virtual manufacturer support.
• ISO Class 7 Cleanroom Manufacture & Assembly Manufacturing and assembly of medical devices within an ISO Class 7 cleanroom environment, taking products from prototype to validated device ready for distribution.
• Packaging Services Medical device packaging services including development of pouches, rigid trays, and validated packaging solutions for sterile device delivery.
• Injection Moulding Plastic injection moulding of medical device components within cleanroom environment, producing complex devices to tight tolerances.
• Extrusion Clean room medical tube extrusion of medical grade thermoplastic tubing with precise ID/OD control, wall thickness management, and biocompatibility compliance.
• Ultrasonic Welding Fast, clean, efficient, and repeatable ultrasonic welding process for bonding thermoplastic medical device components without introducing adhesives or toxicity issues.
• Prototyping / 3D Printing Rapid prototyping and 3D printing services for medical device design validation, offering first-off prototypes and testing/evaluation samples.
• Sterilisation Services Validated sterilisation protocols including Gamma Irradiation and Ethylene Oxide (EO) processing for single-use sterile medical devices.
• CME Product Assembly Controlled Manufacturing Environment for IVDs and medical devices that do not require stringent cleanroom protocols, including complex mechanical and electromechanical assemblies.

Quantifiable outcome

• MDSAP certification enables single audit satisfying requirements of multiple regulatory jurisdictions (Australia, Brazil, Canada, Japan, US)
• +1 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

Four partnerships are on record, tiered minor.

• Oxford Bioscience Network (OBN)minorGTM or Marketing PartnerOBN is a not-for-profit membership organisation supporting and bringing together the UK's life sciences companies, corporate partners and investors. Mi3 joined to engage with the UK life sciences community and understand issues organisations face when bringing new products to market. The network has 400-plus member companies across the UK.
• UK Manufacturing Unite (#UKMfgUnite)minorGTM or Marketing PartnerUK Manufacturing Unite is an initiative created by manufacturers for manufacturers, offering free collaboration between manufacturers and suppliers to help increase UK productivity and re-build the UK economy. Mi3 joined as 'collaborationeers' to drive collaboration across UK manufacturing sectors and support the post-COVID recovery.
• Reshoring UK InitiativeminorGTM or Marketing PartnerReshoring UK is a collaboration of leading industrial engineering associations to assist manufacturers connect with trusted, accredited UK suppliers. Mi3 joined to be recognised as a trusted UK medical device manufacturing supplier and support the UK reshoring resurgence in healthcare manufacturing following Brexit.
• INSTRKTIVminorStrategic or Co-development PartnerCollaboration with INSTRKTIV to create the definitive guide to IFU (Instructions for Use) for medical devices and in-vitro diagnostic products, covering requirements for both US and EU markets.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Integer Holdings: Integer Holdings (formerly Greatbatch) is a major medical device contract manufacturer serving cardiac, neuromodulation, and other therapy OEMs with design, manufacturing, and supply chain services — directly comparable to Mi3's end-to-end medical device manufacturing and design offering.
• Viant Medical: Viant Medical is a contract manufacturer of finished medical devices and components with design, engineering, tooling, moulding, extrusion, and assembly services — overlapping directly with Mi3's offering to medical device OEMs across thermoplastic processing and cleanroom assembly.
• Freudenberg Medical: Freudenberg Medical (including the Helix Medical brand) is a global medical device contract manufacturer offering silicone and thermoplastic processing, extrusion, moulding, and device assembly for medical and pharma customers — a close like-for-like to Mi3's thermoplastic and tubing specialty.
• Spectrum Plastics Group: Spectrum Plastics specializes in specialty plastics processing for medical devices, including injection moulding, extrusion, packaging, and cleanroom assembly — closely matching Mi3's CME and ISO Class 7 cleanroom offerings and thermoplastic engineering focus.
• Phillips-Medisize: Phillips-Medisize (a Molex company) is one of the largest medical device contract manufacturers globally, offering design, development, and manufacturing of plastic and silicone medical components, drug delivery devices, and IVD consumables — overlapping directly with Mi3's cleanroom assembly, injection moulding, and design services for medical device OEMs.
• Nolato Medical: Nolato Medical is a polymer-based medical device and pharma packaging contract manufacturer with injection moulding, cleanroom assembly, and IVD capabilities — comparable to Mi3 as a European-headquartered CDMO serving medical device and IVD customers with similar services.
• Biomerics: Biomerics is a vertically integrated medical device contract manufacturer offering design, development, extrusion, injection moulding, and cleanroom assembly for interventional, cardiovascular, and surgical OEMs — directly comparable to Mi3's end-to-end capabilities and target customer base.

Others

• Eurofins Medical Device Services: Eurofins provides medical device and IVD testing, regulatory, and contract laboratory services — comparable to Mi3 as an adjacent ecosystem participant in medical device regulatory compliance and contract services rather than a direct manufacturing competitor.

Broad incumbents

• West Pharmaceutical Services: West Pharmaceutical is a large established player in drug delivery components, packaging, and contract manufacturing for injectable and medical device customers — a broader incumbent whose containment, sealing, and device assembly capabilities overlap with Mi3's sterile packaging and medical device assembly offerings.
• Gerresheimer: Gerresheimer is a major glass and plastics primary packaging and medical device manufacturer serving pharma and medical customers globally — a broad incumbent whose plastics division overlaps with Mi3's sterile medical device packaging and component manufacturing activities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mi3