Diagnostics Medical Devices

The growing number of chronic diseases along with the expanding geriatric population has led to a drive in research and development, increasing the trend in early disease detection and maturing the clinical diagnostic market. Despite the most popular devices belonging to the point of care (POC) category and the existence of pregnancy and glucose over-the-counter self-tests, the wide range of diagnostic devices including highly sophisticated DNA technology. This category includes reagents, calibrators, control materials, kits, software and related instruments.

Whilst outsourcing in the diagnostic devices market ranges from laboratory product development through to accompanied pharmaceutical R&D, SteriPack assists in the whole processes, starting from device design for manufacturing assessment and packaging development all the way to market delivery. SteriPack’s expansive regulatory and industry experience and established processes helps to ensure smooth transitions to meet challenges and needs.

In vitro (IV) diagnostic services at SteriPack:

  • Design and development (design review, robust design, DFM, DFA)
  • Cleanroom injection molding
  • 3D Printing and additive manufacturing
  • Assembly
  • Kitting
  • Sterile barrier packaging
  • Process validation
  • Quality and microbial testing 
  • Material sourcing
  • Regulatory support
  • CE marking

SteriPack’s contract services are designed to support Customers at every stage of product development. Both regulatory and industry experience helps to proceed smoothly through all requirements and needs.

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Data Protection Policy: With accordance to the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) you have the right to withdraw your consent at any time, however in case you withdraw your consent, we will not be able to contact you. To withdraw your consent, please, contact us by email and describe the field of objection: GDPR_consent_withdraw@steripackgroup.com. You have the right to access personal data, rectify, delete or limit their processing, the right to objection, the right to transfer data, the right to lodge a complaint with a supervisory authority. The personal data controllers are joined companies from the SteriPack Group indicated below: 1) Poland: SteriPack Medical Poland sp. z o.o., Łęg, ul. Japońska 1, 55-220 Jelcz-Laskowice, 2) Ireland: National Science Park, Dublin Road, Petitswood, Mullingar, Co. Westmeath, N91 TX80, Ireland, 3) US: 4255 S. Pipkin Road, Lakeland, Florida 33811 , 4) Malaysia: Lot 119992, Jalan Canang Emas 8, Telok Gong Industrial Estate, Klang 42000, Selangor. 5) Europharma Concepts Ltd. Kilbeggan Road, Clara, County Offaly, Ireland. Withdrawal of consent for one of the companies means the withdrawal of consent for the whole SteriPack Group. Offers will be submitted by a company from the Group that best suits the expectations both in terms of location and other conditions established during the communication taking place on the basis of the granted consent. Please find more information on the steripackgroup.com, the „Privacy Policy“ tab.

Typical application areas:

blood test vials, allergy tests, breath monitoring devices.

medical devices injection moulding