With extensive experience in medical device compliance and manufacturing, Teampac provides a reliable and efficient pathway to market. By outsourcing your legal manufacturer role to us, you can let us navigate the complexities of EU medical device regulations and concentrate on your core business.

Partnering with Teampac as your CE mark holder offers the following benefits:

• Accelerated market entry: Our expertise in regulatory compliance shortens time to market.
• Reduced regulatory complexity: We handle the intricate details of compliance so you don’t have to.
• Focus on core business: You can concentrate on branding, sales, and clinical development while we manage the regulatory requirements.
• Customizable solutions: While we follow standardized processes, we tailor documentation and compliance efforts to suit each customer’s specific needs.

Teampac’s role as a CE mark holder:

• Compiling and maintaining the technical file
• Managing certifications to ensure compliance throughout the device lifecycle
• Maintaining Quality Management Systems (QMS) and risk management frameworks
• Handling regulatory registrations and audits
• Overseeing manufacturing, packaging, and release for sale