Our current most popular services
Governance, Quality, Regulatory, Risk and Compliance Service
We provide a comprehensive external quality assurance service that helps UKAS-accredited laboratories reduce and eliminate risks to the business, enhance functions, and meet organisational aims and objectives.
Our service is designed to provide extensive support for, regulatory inspections, navigating major and critical NCRs, mitigating internal and external business risks, and ensure the best-in-class customer experience.
By partnering with us, businesses can focus on growth and further development, while we support regulatory and notified body inspections and provide quality assurance activities.
ISO 15189:2022 Transition
With the release of the new standard, we are here to ensure your successful transition. Our expert assistance will guide you through the process, ensuring a seamless adoption of ISO 15189:2022.
Medical Device Regulatory Services
Our medical device regulatory services offer comprehensive support and expertise to navigate the complex landscape of medical device regulations. We understand the challenges faced by medical device companies in obtaining regulatory approvals, complying with global standards, and maintaining compliance throughout the product lifecycle. Our team of regulatory specialists provides tailored solutions to streamline the regulatory process, minimize risks, and accelerate time to market.
Our medical device regulatory services cover a wide range of areas to ensure compliance with regional and international regulations, including:
- Regulatory Strategy Development: We work closely with your team to develop a customized regulatory strategy that aligns with your business goals. Our experts assess the regulatory requirements specific to your target markets, assist in determining the appropriate regulatory pathway, and create a roadmap for successful product approval.
- Pre-Market Regulatory Submissions: Our team prepares and submits regulatory dossiers on your behalf, including pre-market notifications, 510(k) submissions, pre-market approval (PMA) applications, and CE Mark applications for European market access. We ensure that all required documentation, such as technical files, clinical data, and labeling, are compiled and presented according to regulatory guidelines.
- Quality Management Systems: We assist in establishing and implementing robust quality management systems (QMS) that comply with regulations, such as ISO 13485 and FDA Quality System Regulation (QSR). Our experts provide guidance on process development, risk management, post-market surveillance, and complaint handling to ensure ongoing compliance and product safety.
- Post-Market Compliance: Our services extend beyond initial market entry. We support post-market compliance activities, including adverse event reporting, post-market surveillance, labeling updates, and periodic safety updates. We help you navigate post-market requirements to maintain compliance and respond effectively to regulatory inquiries.
- International Regulatory Compliance: With a global perspective, we help you navigate international markets by assisting with regulatory submissions for countries beyond your home market. Our experts are well-versed in the regulatory requirements of various regions, such as the US FDA, European Union Medical Device Regulation (MDR), and other international regulatory frameworks.
- Regulatory Training and Consultation: We offer regulatory training programs to enhance your team’s understanding of medical device regulations and compliance requirements. Additionally, our consultants provide ongoing support and guidance to address any regulatory challenges, interpret changing regulations, and assist with regulatory audits or inspections.
Partnering with our medical device regulatory services provides you with the expertise and resources needed to successfully navigate the regulatory landscape. Our goal is to streamline the regulatory process, mitigate risks, and ensure your medical devices comply with all relevant regulations, allowing you to focus on innovation, quality, and improving patient outcomes.