,Why Compliance Matters Now More Than Ever
The opportunity to secure your position in China’s market is gradually closing. Since over 61% of US-based and 58% of EU-based companies began sourcing away from China due to regulatory issues, businesses that obtain ISO 9001 certification and adhere to China GMP certification, and GSP compliance now stand to benefit significantly. Compliance is not a choice — it is essential to remain relevant and profitable in this saturated environment of China medical device regulation and Chinese medical equipment companies.
Benefits of Usability Testing
Discover how Freyr Solutions' FDA-recommended usability testing can enhance your medical devices
- Validate device efficiency and effectiveness.
- Ensure seamless integration into user routines.
- Prioritize safety through rigorous testing protocols.
- Reduce user errors.
- Facilitate regulatory approval.
Experience seamless approval process for Human Factors compliance
Our Services: Every Compliance Measure Taken
ISO 9001 registration is a critical move that will help you realize high-quality results and build product credibility within the company. At Freyr Solutions, we guide you through compliance with necessary standards, strategically positioning your business for success in the regulated Chinese market.
GMP compliance is mandatory, especially for firms involved in medical device registration in China. Failing to meet these guidelines can result in costly delays and lack of market access. Our China GMP consulting services cover everything from audit preparation to ensuring future with China GMP regulations.
Adhering to GSP requirements is mandatory for organizations managing complex supply chains. Research from 2023 shows that 40% of firms view supply chain digitization as key to improving visibility and traceability, making GSP certification even more critical. Our consultants assist you in securing China GSP certification, ensuring quality from production to market.
Companies that operate at the center of a complex supply chain need to adhere GSP requirements to the letter. From a 2023 study, it is established that 40% of firms see supply chain digital transformation as essential in enhancing the visibility and traceability of the GSP to make certification even more important. Our consultants help you in getting the GSP certification, quality right from production to the market.
Why Choose Freyr Solutions?
We at Freyr Solutions understand the certification process of any organization in China for ISO, GMP, and GSP. Our consulting services are customized to fit your needs; enabling compliance with legal regulations and sales performance in this cut throat market environment.
Before it’s too late is what you should not wait for. There is the truth in saying that whereas firms are becoming increasingly more compliant in China, those who are taking the initiative now will triumph. Ensure you are relevant by working with the services of Freyr Solutions for your certifications.
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
