Our team has a wealth of experience in clinical trials, medical devices, product development and the associated regulatory landscape. 
​This means we are well placed to help MedTech companies:

• Define a business and product strategy that integrates both the regulatory path and market access ​
• Help implement the strategy with hands-on regulatory and clinical investigation support

We also work with organisations looking to use digital health technologies. We support:

• Pharmaceutical companies looking to use digital health products in clinical trials of a investigational drug
• Researchers wanting to enhance their studies with wearable devices but unsure how to go about it.

Digital Health Landscaping

This work can include:

• Evaluation of the products available on the market and their suitability for a particular endpoint or study outcome
  • Reports and recommendations
  • Support evaluating products in a relevant population
  • Support with data analysis and data management, ensuring privacy and security of data

Strategic Advice

We provide strategic advice on regulatory and commercial strategy related to digital health to MedTech companies looking to develop new products or reposition existing ones. ​

"Ensuring companies have an effective business and product strategy the integrates the regulatroy path and market access is key to success"

Regulatory Collaborations

"We work with product teams to Develop regulatory competency in-house"
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Regulatory Strategy

Interaction with regulators

ISO 13485 QMS

Risk Management

Technical File documentation

Software as a Medical Device (IEC 62304)

Cybersecurity
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Clinical Evaluations

We work with you to support your regulatory path, including:

• Defining a regulatory strategy, whether you already have a device on the market or are just starting out
• Supporting regulatory engagement as a way of validating your strategy (including confirming if a product can be considered exempt from medical device regulations)
  • ​Setting up meetings with regulators
• Developing your team’s regulatory expertise including support in setting up and enhancing your Quality Management System to enable efficient execution
• Systems to ensure operational smoothness and compliance (GCP, medical device, privacy, etc.)
• Navigating the evolving medical device regulatory landscape in the EU and US, this includes:
  • Device Classification
  • FDA Software as a Medical Device guidance,
  • FDA / EU cybersecurity guidance,
  • FDA pre-submission meetings etc
  • supporting FDA 510k submissions
• Understanding how to use risk management frameworks (e.g. IMDRF)

Device Validation and Clinical Investigations

Under MDR, the focus on clinical validation is more onerous, we can help you implement the necessary clinical validation.

• Designing smart studies for your clinical evaluation or clinical investigations
• Preparing clinical investigation documentation for submission to ethics committees and regulators. 
• Effective use of data from products on the market to underpin the clinical evaluation for your next generation product(s)​
• Ensuring you have procedures in place to cover Sponsoring clinical investigations (ISO 14155)
• Help finding clinical partners to deliver your study.