High Edge Consulting

Summary

High Edge Consulting works with companies in the medical device sector to ensure they operate within the relevant regulatory framework, and that they comply with the quality systems demanded by their products.

Profile

High Edge Consulting provides regulatory and quality systems services worldwide, including Europe, USA, Canada, Australia, New Zealand and Japan. 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 78 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.

High Edge Consulting can assist with:

• CE Marking, 510(k), CMDCAS and other Worldwide Regulatory Compliance,
• Specific projects such as technical file authoring, sterilisation validation, 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, urgent need),
• Resolution of Auditor findings,
• Global coverage - including USA, Canada, Australia, Europe and others,
• Medical Devices Training,
• Candidate screening for regulatory and quality positions.

For more information, visit www.highedge.co.uk