Medical Device Consulting from High Edge Consulting

High Edge Consulting helps you turn the challenge of regulatory and quality compliance into business improvements.

Our expertise in medical device directives and standards means that we take a solution-based approach that is tailored to your needs and is fully compliant. Backed by over 80 years of combined experience across sterile and non sterile devices, you can be confident that we will break the regulatory bottleneck, on time and on budget.

Services We Offer

High Edge Consulting offers a full range of consultancy services. Our six key service areas provide the right balance of on-going practical support and specialist knowledge to help you focus on and grow your business.

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  • EU Authorized Representative

    For manufacturers and distributors based outside of the European Union, appointing an Authorized European Representative is an essential step to market in the region.

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  • Regulatory Affairs

    Achieving regulation is a vital stage to getting your medical device on the market, and maintaining ongoing compliance. Lack of resource, deadlines creeping forward, specialist projects and knowledge gaps are common hurdles that need to be overcome.

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  • Quality Assurance

    The key milestones of your Quality Management System have slipped. You may be unhappy with your current system. There are just too many CAPAs open and overdue. Your management review and external audits have not been completed.

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  • Contamination Control & Microbiology

    Your product’s reputation will stand or fall depending on patient safety. This will certainly be the number one priority for medical device companies.

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  • Sterilisation

    With sterile devices, ensuring your sterilisation method is validated, tackling quarantined or failed batches and resolving questions raised by your Notified Body will be crucial.

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  • Auditing

    Auditing is a vital part of compliance and maintaining a quality system but is often pushed down the priority list with limited time and resource issues. Sometimes, staff can be too close to the business and require an impartial individual to provide an objective and realistic viewpoint.

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    • Public Training Courses

    We provide training courses specifically for medical device manufacturers and their suppliers.

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