Branding


Why is it so important to review and update your regulatory strategy?

Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of the new MDD and further changes planned for the coming years, it is important that a regulatory strategy is reviewed and updated as new and updated requirements are identified. New requirements and/or updates could have a significant impact on existing or new products. Regulatory standards are used to assess the safety, efficacy and quality of medical devices throughout the product lifecycle. There’s......

Continue Reading


Why is regulatory strategy so important?

The global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies. With many changes planned for the next few years, a regulatory strategy ensures that you are well informed and aware of all existing requirements as well as any new or updated ones, which may impact the marketing of your device. We define the regulatory strategy as the ‘roadmap to market’ – because this describes the regulatory requirements that need to be addressed. There are a......

Continue Reading


Tips for transitioning to ISO 13485:2016

Transition planning is critical As the March 2019 deadline for ISO 13485:2016 is fast approaching, now is the time to start actively planning for the transition. When planning for the transition, it is important to consider the resources and time required to update your Quality Management System (QMS) as well as regulator assessment times. In addition, companies must also define the project so that there is clear understanding of the specific processes that need the most work and the impact that this work has on any other requirements. Planning considerations We recommend......

Continue Reading


The CE Mark matters in medical markets

Selling any product into the European market can be simplified if a manufacturer can show that it complies with appropriate regulations. For medical device manufacturers, this compliance is vital.  Regulatory strategy planning is a critical step in the development and marketing of any medical device so it is important to understand the regulatory requirements of target markets, which can be quite different from country to country. It is equally important to have a clear understanding of the intended use, indications and claims for a device as these influence how to classify or......

Continue Reading


Do you have a medical device and don’t know what to do? Medical devices include a wide range of products from bandages to heart valves and in most regions, the term medical device also includes in vitro diagnostic (IVD) devices. If you are lost in the regulatory maze, don’t panic, KD&A can help you out. The Medical device regulatory framework is complex and varies significantly from device to device and region to region. KD&A has more than 21 years of experience working hand in hand with manufacturers, sponsors and distributors through the......

Continue Reading