Ensuring compliance with European Union (EU) regulations is a critical step in bringing medical devices to market.
For companies looking to streamline this process, partnering with an experienced legal manufacturer can provide significant advantages. As a trusted contract manufacturing partner, Teampac takes on the regulatory responsibilities, allowing you to focus on your core business activities such as branding, sales, marketing, and distribution.
Accelerate Market Entry with Teampac’s CE Mark Expertise
At Teampac, we understand the challenges of ensuring compliance with EU regulations. As your dedicated CE mark holder, we collaborate closely with you to understand your unique needs, crafting tailored solutions that suit your requirements.
Our role as your CE mark holder includes:
- Compiling and maintaining the technical file
- Managing certifications to ensure compliance throughout the device lifecycle
- Maintaining our own Quality Management Systems (QMS) to support compliant manufacturing and risk management for our customers
- Handling regulatory registrations and audits
- Overseeing manufacturing, packaging, and release for sale
You retain ownership of your brand, clinical expertise, and market strategy, while Teampac expertly manages the regulatory framework. This partnership enables you to bring your products to market faster, more efficiently, and with confidence.
How Teampac Simplifies Your Path to Compliance
– Our mission is to simplify the regulatory process so our customers can focus on what they do best: developing and delivering innovative medical solutions to the market, says Jyri Temonen, CEO of Teampac.
By partnering with Teampac as your CE mark holder, you gain the following benefits:
- Accelerated market entry: Our deep regulatory knowledge shortens your time to market, allowing you to reach customers faster.
- Reduced regulatory complexity: We handle the intricate details of compliance, streamlining the process so you can focus on growth.
- Focus on core business: Leave the regulatory burden to us while you concentrate on sales, branding, and product development.
- Customizable solutions: Although we follow standardized processes, we tailor documentation and compliance efforts to suit your unique needs.
Who Should Consider Outsourcing CE Mark Responsibilities?
Teampac is proud to offer a solution for companies seeking to simplify their regulatory journey. As we expand our services as a CE mark holder, we are already seeing strong interest from customers exploring the benefits of transferring their CE mark responsibilities to us.
Teampac’s CE mark holder services are particularly beneficial for:
- Small and medium-sized enterprises (SMEs) looking to outsource regulatory responsibilities
- Larger companies seeking to focus on their core products while outsourcing compliance and manufacturing of their accessory products
- Companies transitioning production to a trusted partner for efficiency and regulatory support
End-to-End Compliance: We Handle Your Documentation with Precision
– Compliance is not just a requirement, it’s a strategic advantage. At Teampac, we ensure that every step of the process meets the highest regulatory standards, giving our customers confidence in their product’s market readiness, highlights Temonen.
As part of our service, Teampac manages a comprehensive set of documentation, ensuring full compliance with EU regulations. This includes:
- Quality agreement outlining roles and responsibilities
- Technical file maintenance
- Device description, labeling, and instructions for use
- Design, verification, and validation documentation
- Risk management file, clinical evaluation plan and report
- Post-market surveillance plans (PMS)
Achieve Market Readiness with Teampac by Your Side
At Teampac, we see ourselves as more than just a service provider – we are your committed partner in navigating the regulatory landscape. With years of expertise in medical device compliance and manufacturing, we offer an efficient, reliable pathway to market success.
– By partnering with Teampac, companies can overcome regulatory hurdles quickly and confidently. We work closely with you to ensure that every aspect of your product’s journey is compliant and market-ready, concludes Temonen.
If you’re ready to streamline your path to compliance and work with a team that values your success, contact us today. Let’s discuss how we can support your medical device journey and become your trusted CE mark holder.
