We are specialized in offering full-spectrum regulatory, quality management, and compliance services tailored to medical device and in vitro diagnostic manufacturers. Our expertise ensures that clients can efficiently bring their products to market while meeting global regulatory and quality standards.
1. What Sets [Company] Apart:
1.1. Global Regulatory Representation
We act as your EU Authorized Representative, UK Responsible Person (UKRP), Swiss (CH-REP) Representative, and US Agent, providing comprehensive compliance support across key global markets. With offices in the EU, UK, Switzerland, and the US, we ensure that our clients benefit from local expertise and fast response times, giving them peace of mind in navigating complex regulatory requirements.
1.2. Design and Implementation of Tailor-Made Quality Management Systems
We design and implement custom Quality Management Systems (QMS) compliant with ISO 13485 and US FDA requirements. These systems are specifically tailored to the needs of medical device manufacturers and in vitro diagnostic manufacturers, ensuring adherence to both international quality standards and local regulatory demands. Our QMS solutions help companies streamline their processes, maintain compliance, and ensure ongoing quality management.
1.3. Regulatory Expertise Backed by Strong Credentials
Led by a person responsible for regulatory compliance (PRRC), registered at the EU level, and recognized by the Dutch IGJ (Health and Youth Care Inspectorate), we bring deep expertise to EU MDR/IVDR compliance. Our clients gain access to a highly experienced team that ensures products meet the strictest compliance standards, minimizing regulatory risk.
1.4. End-to-End Compliance Solutions
We offer various services, including regulatory representation and technical product documentation support. From market entry to post-market surveillance, we provide a seamless compliance pathway, ensuring all regulatory and documentation requirements are met across jurisdictions. This end-to-end approach allows our clients to focus on innovation while we manage their compliance needs.
1.5. ISO 13485 Compliance
Our management system fully complies with ISO 13485, the international standard for quality management systems in the medical device industry. This ensures our client's products meet global quality requirements and regulatory expectations, building confidence and ensuring market access.
1.6. Accredited and Respected
As an associate of the EAAR (European Association of Authorized Representatives) and with leadership registered as a Principal Auditor at CQI/IRCA, our firm is recognized by industry leaders for maintaining the highest standards of compliance. Our accreditations reflect our commitment to providing reliable, high-quality services that support our clients' regulatory and quality management needs.
1.7. Decades of Industry Experience
With over 19 years of experience in Notified Body and CAB audits and extensive expertise in clinical risk management and high-level intensive care, we understand the complex landscape of regulatory compliance and patient safety. This allows us to offer effective, practical solutions tailored to the unique challenges medical technology companies face.
2. Why Choose Us:
- Global reach combined with localized expertise in key markets.
- Tailor-made QMS solutions compliant with ISO 13485 and FDA requirements.
- Comprehensive regulatory representation and technical documentation services.
- Accredited expertise with recognized leadership in regulatory compliance.
- Client-focused solutions to navigate complex regulatory landscapes effectively.
- Contact us today to learn how we can help you achieve regulatory compliance and implement quality management systems that meet the highest standards.
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