High Edge Consulting - Regulatory Affairs and Quality Systems Compliance Consultancy

High Edge Consulting provides worldwide regulatory affairs and quality systems compliance for Europe, the US, Canada, Australia, New Zealand, Japan – in fact, anywhere where quality medical devices are sold.

We employ a team of experts in the field to help medical device manufacturers to be conversant with and comply with the relevant international standards and directives. The efficient and effective way we work with our clients maximises the communication, which in turn leads to bringing projects in on time and on budget.

Regulatory affairs support for medical device companies

High Edge Consulting can support your business at times of growth, when there may be skill or knowledge gaps or for short-term resourcing issues. High Edge Consulting can assist established medical device companies with:

• CE marking, 510(k), CMDCAS and other worldwide regulatory compliance
• Specific projects such as technical file authoring, sterilisation validation and internal auditing
• Covering skills gaps
• Filling knowledge gaps
• Supporting growth into new markets
• Supporting growth with new product lines
• Specialist fields (microbiology, sterilisation, risk management, clinical evaluations and biological reviews)
• Interim cover (maternity, sickness or urgent need)
• Resolution of auditor findings
• Global coverage, including the US, Canada, Australia, Europe and others
• Medical devices training
• Candidate screening for regulatory and quality positions

Regulatory affairs and quality systems compliance support

Companies that are new to the medical device industry often need help to achieve the knowledge and skill required to comply with medical device regulatory and quality requirements thus avoiding costly wrong decisions being made and deadlines being put back time and time again. High Edge Consulting has vast experience in assisting new companies and existing companies moving into the medical device arena. We can:

• Provide a one-stop-shop for quality and regulatory requirements
• Create an ISO13485 quality management system specifically for medical devices
• Complete the necessary documentation to ensure CE marking
• Create a US-compliant 21 CFR 820 quality management system
• Compile submissions to the US regulatory body (FDA - 510(k)) and other worldwide regulatory compliance
• Write / compile product technical or design dossiers files
• Offer support from initial design to product launch and beyond
• Answer technical questions
• Offer advice on best practice and industry standards
• Provide staff training
• Provide cleanroom monitoring and support - practical and realistic solutions
• Undertake candidate screening for regulatory and quality positions

Regulatory compliance and auditing consultancy services

Whether you are new to medical devices or an experienced manufacturer, our experts can help you, from completing a technical file, drafting the requirement for the US regulatory body (the FDA) with a 510(k) submission, and determining the optimum sterilisation methodology, to auditing to the latest medical device regulations.

Our highly experienced and qualified staff can undertake small or large projects, whether for long term, on-going support, process implementation, systems and workflow maintenance, filling the gaps in resources or cover for ad hoc days.

It doesn't end with the paperwork. If your team requires training, we have experts on hand that can work with them to maximise their effectiveness.

We provide consultancy in the following areas:

• UK / EU regulatory compliance
• Worldwide compliance to the relevant directives
• Sterilisation – gamma, electron beam, ethylene oxide and steam
• Microbiology and contamination control
• Interim support
• Quality management system
• Auditing
• Process validation
• Interim support
• Medical device auditing services
• Auditing regulatory and quality compliance
• EC rep