Medical services for health technology

Our medical writers have a high level of training and they will be pleased to support you with their knowhow. Whatever the issue, they will be able to clarify it for you, from medical writing to marketing materials compliance for medical devices (MD) and in vitro diagnostic (IVD) medical devices. At DRA, we know the marketing legislation, regulations and industry Codes of Ethics in countries across the Nordics. We’ll support your marketing team and find the best options for your products.

Our medical services for MD and IVD devices include:

  • Medical writing​ and review​
  • Literature searches and data analysis​
  • Medical Advisor support and training services
  • Verification and validation reports​ for pre-clinical studies
  • Clinical evaluation plans and reports including biological safety evaluation (ISO 10993)​
  • Risk management (ISO 14971)​
  • IVD performance evaluation​
  • Preparation and assessment of marketing materials and marketing measures
  • Management of medical information enquiries and product complains and feedback​

Our medical services include writing documentation for medical devices, such as expert statements, clinical/performance evaluation plans and reports, documentation for registration, pre-clinical plans and reports and other scientific documentation.

We can help you with medical content or marketing compliance reviews including evaluating claims. Our experts will review your claims and messaging to ensure that they are accurate and stand up to scrutiny, and that your references are valid in the Nordic region. We can review labelling, instructions for Use (IFU) and all kinds of promotional materials and translate them into other languages. ​Furthermore, our team will use the correct style of language to reach your target audience and to support your business’s image.​

Our team combines fluent language with expertise in different types of health technology and MD and IVD devices, as well as knowledge of administrative regulations, QMS documentation and the most recent Medical Development Coordination Group (MDCG) guidelines in use in Europe. Whatever the issue, they will be able to clarify it for you, from understanding registration and application procedures, to medical writing, marketing materials compliance, post-market surveillance, device vigilance and price and reimbursement matters.