The global medical device industry is one of the fastest-growing healthcare markets, with a projected value of over USD 600 billion by 2025. As wearable and software technology rapidly expand into healthcare, new guidelines under the EU’s Medical Device Regulation (MDR) are set to increase the scrutiny on all medical products to ensure patient safety and device performance. A higher bar set by both the EU and China means more work for device manufacturers to meet the quality standards for regulatory documentation and higher risk for regulatory and market strategy.

We support our clients to prepare and maintain their Clinical Evaluation Reports (CERs) to meet both the current MEDDEV 2.7/1 Rev4 and new MDR standards. We are available for assistance in all aspects of CERs, including consulting and writing support for China.

The pharmaceutical and healthcare industry has witnessed significant changes in the last ten years due to rapid advancement in the regulatory landscape, economic infrastructure, and continually evolving customer behaviour. New technology and its broad, swift social integration is at the leading edge of these changes.

Our medical affairs experts are well versed with the healthcare landscape and offer in-depth knowledge and expertise in all aspects of medical affairs. We help pharmaceutical companies and medical device organizations communicate scientific value of the highest relevance with stakeholders by overseeing all aspects of medical communication and manage complex and specialized information. Our team provides support in client outreach by preparing content in engaging formats, helping prepare strategic communication plans as well as executing them.