Medical Device Assembly & Packaging

Medical device assembly services provide specialized assembly and packaging for medical device manufacturers requiring clean room facilities and strict quality systems.

With medical device market worth $450+ billion and companies outsourcing assembly, specialized assemblers generate revenue of $200,000-$650,000 annually with profit margins of 30-45% through assembly contracts.

The business requires clean room or controlled environment, validated processes, quality management system (ISO 13485), and trained staff.

Services include sterile and non-sterile assembly, component inspection, packaging, sterilization prep, and documentation.

Pricing typically $3-$30 per unit depending on complexity and regulatory requirements.

Success factors include ISO 13485 certification, validated processes, comprehensive documentation, and quality consistency.

Common products include diagnostic kits, surgical instruments, disposable medical devices, and healthcare products.

All work requires extensive documentation and traceability.

The business requires significant investment in facility and quality systems but commands premium pricing due to specialized requirements.

Marketing focuses on demonstrating certifications, quality systems, and medical device industry relationships.

With medical device innovation continuing in 2025 and companies seeking US-based qualified assembly partners, medical device assembly offers opportunities for entrepreneurs willing to invest in regulatory compliance and quality systems for this specialized, high-value market.