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Certified manufacturing partner is a strategic choice for dual-use device designers

Project timeline:
months
Service areas:
Manufacturing
Written by
Teija Tulinen
Innokas content creator
Innokas employee on a laptop with accompanied by "Innokas sustainability report 2024" title

Designing and manufacturing devices fit for dual-use purposes requires strict compliance with standards, regulatory requirements, and meticulous documentation. Choosing the right manufacturing partner is a strategic move that impacts product safety, market access, and cost-efficiency. The choice goes far beyond being just about procurement Päivi Isomäki, Head of QMS at Innokas, explains three key points of how a manufacturing partner with a certified Quality Management System acts as an insurance to dual-use products.  


1. Certified expertise builds trust, reduces workload, and saves costs

A partner with long-standing experience and a certified quality management system brings refined processes and deep knowledge of regulated industries where dual-use products tend to exist. Certification from a reputable third party serves as proof that the partner operates according to required standards, effectively minimizing the need for customer audits and in-house inspections. This turns into tangible cost savings and allows customers to focus their resources on core activities. Additionally, continual renewing of certification demonstrates the partner’s long-term commitment to quality.

2. Quality system enables outsourcing and export control management

A well-functioning, certified quality system allows customers to outsource certain operations such as documentation, recordkeeping, and even export control. This is especially important for dual-use products, where requirements may vary depending on the intended use. An experienced partner can provide critical support, particularly for companies with limited internal resources.

3. Certified partner is investment in the success of a dual-use product

Standards guide the design, safety, and testing requirements of devices. A partner who actively monitors and applies harmonized standards can help innovative companies stay compliant in a constantly evolving regulatory landscape. This expertise is transferred to the customer through partnership and ensures that devices meet requirements for both civilian and military use.

A certified manufacturing partner is an extension of your quality management, risk mitigation, and competitiveness, far beyond being just a supplier. When choosing a partner, look for experience, certified expertise, and the ability to support you throughout the entire product lifecycle.

Innokas operates two certified manufacturing sites, each with its own specialty to suit the needs of our customers where they need it. For over 30 years, we’ve delivered to certified standards across highly regulated industries. If this article sparked any questions or thoughts, we’d be happy to continue the conversation.

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Interviewee


Päivi Isomäki

Head of QMS

paivi.isomaki@innokas.eu

Lead Magnet: The 101 of medical technology innovation
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