High Edge Consulting

Quality Systems | Regulatory Affairs | Contamination Control and Microbiology
Sterilisation | Validation | Training

If you are looking to implement ISO 9001 or ISO 13485 into your business, we have a variety of options available to you. Whether you wish to implement a quality system yourself, require a consultant to create a strategy for your proposed Quality System, or a contractor for some hands on resource to help you through your accreditation, High Edge Consulting have a wealth of experience in providing all aspects of Quality System work. For ISO 9001 implementation we have developed an exclusive product, ISO KITTM, that gives you the choice in how you want to implement ISO 9001 into your business. Implementation of ISO 13485 is a specialist area that requires consultants who know their subject. Our ISO 13485 consultants have previously worked in the medical device industry and implemented ISO 13485 successfully into many medical devices manufacturers and associated suppliers.

If you already have an established ISO 9001 or ISO 13485 system and need assistance in the management and maintenance of it, High Edge Consulting can offer maintenance contracts to fit your requirements whether it be for 6 days consultancy over a year or 1 or more days a month. In fact, whatever your requirements, High Edge Consulting can help you to improve, refine and to keep on top of your Quality System with the absolute minimum of fuss.

High Edge Consulting also offers service agreements. For a fixed monthly payment you receive consultancy support and depending upon the service agreement purchased, you can also receive pre-audits, internal audits, on-going staff training and assistance with your annual management review.

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With a wealth of industry experience in Medical Device Manufacturing, High Edge Consulting can provide you with a consultant who can be of real benefit in your Regulatory Affairs. Whether your requirements are for assistance on implementing or interpretation of the Medical Device Directive 93/42/EEC and CE Marking, which conformity assessment route to take or ensuring you meet the essential requirements, High Edge Consulting can provide you with the expertise you require. We can assist you with Technical files, Clinical data evaluation and Post Market Surveillance and Vigilance issues. If you have recently had an audit that resulted in minor and or major non conformances we can help you to resolve them and using our service packages (see comparison chart) can help to prevent them happening again. Do you currently sell your medical device into Canada or do you want to start selling into Canada? High Edge can provide you with the expertise to implement and conform to Canadian Medical Regulations SOR/98 282. We also have expertise in Title 21 CFR Part 820 of the FDA requirements and can assist in getting your product into the United States.

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How clean is your cleanroom ? At High Edge Consulting we have considerable experience in helping manufacturers to minimise their Cleanroom contamination. If you have cleanroom concerns we can troubleshoot your cleanroom for you. We can give you an impartial view of your cleanroom by examining the layout, working practices, operator behaviour, cleaning materials, cleaning regimes, entry and exit procedures, clothing requirements and Cleanroom location in relation to other aspects of your facility. We can advise you regarding your cleaning materials, frequencies and practices that are necessary to reduce the contamination that does occur within your cleanroom. Any recommendations would balance the risk to contamination against the costs involved in providing the solutions, as appropriate to your needs. We can advice you on tests to demonstrate that your product is in particulate and microbial controlled.

You may not have the resources or business need to employ a full time Microbiologist. High Edge Consulting can provide you with a consultant Microbiologist who is professionally qualified. They can explain tests that are required to you, set warning and action limits for each test. If you have no historical test history we can still approve your test results based on our experience and professional judgement until you have developed enough history to allow us to set your limits. Our consultant can liaise directly with the test laboratory and receive test reports (or copies) direct and review each test result as it becomes available. Our Qualified Microbiologist can sign off each report on your behalf as acceptable or not acceptable, and in the case of the latter can recommend immediate and relevant corrective action that you need to take to minimise any down time. We can also trend your results for you and send you monthly updates showing trends in your testing. This can be an invaluable aid in pre-warning of impending problems – Prevention is better than cure.

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With a substantial knowledge of sterilisation, especially but not limited to medical devices, our consultants offer independent impartial advice. We can help you identify the most appropriate method of sterilisation for you product. We are fully conversant with the requirements of ISO 11137:1995 and BS EN 552:1994; ISO 11135:1994 and BS EN 550:1994; ISO 11134:1994 and BS EN 554:1994.

We will consider the most appropriate sterilisation technology for your product based on the materials from which your product is made and the speed of sterilisation processing turn around you require. There are, of course, other factors we consider such as processing costs, product design features and ability to validate the sterilisation process, all of which will have an impact on the final choice of technology for your product. As we are independent we will serve your best interest and provide you with an unbiased choice of sterilisation technology.

Often the choice of technology is only considered once a product has been made. By considering the options early on in the design stages the consequences of routine sterilisation can have a much lesser impact on processing costs and product turn around. Using our consultant on Sterilisation at the design stage may in the long term prove prudent and pay for itself many times over.

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We always strive to deliver exceptional customer service allowing you to spend your time on other issues. At High Edge Consulting we can apply the principles of validation to any of your validation projects and have specific skills and understanding in the following areas:

• Cleanroom Performance
• Cleanroom Environmental Monitoring
• Sterilisation by Ethylene Oxide
• Sterilisation by Irradiation
• Bioburden Recovery Methods
• LAL inhibition/enhancement studies
• Ethylene Oxide Gas Residuals Decay
• Process Change

We can project manage your validation activities, plan the validation, liaise directly with any subcontractors, check interim results and ultimately provide a formal summary report. We can write your validation protocol, ensuring to cover your requirements in detail so that all parties are fully aware of their responsibilities. Or, where a sub-contractor normally produces their own standard protocol, we can review this with your needs in mind so that you get what you need from the exercise. We can keep things moving, keep you informed of progress during the validation itself. On completion of the validation we will review all the raw data for accuracy before pulling together the information to produce a formal summary validation report written in terms suitable for your own use.

Whatever your level of need, we can provide you with a consultant who has had direct experience of any of the validation topics listed above and who understands the regulatory requirements and above all understands your needs.

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Training of staff is one of the most important investments you can make. We all know that the key to the success of our business is our staff. Only properly trained staff can operate effectively and perform their role satisfactorily. On going training for existing staff is just as important as for new staff.

The training courses we offer include general areas and we can create any bespoke courses relevant to our portfolio. Our courses whilst general in nature are always tailored to reflect your business operations. This gives your staff genuine familiarity with what they are being taught on the course making the training session much more pertinent to their day to day routine.

Our training courses are priced per course, not per person. Bespoke training courses are priced according to content of the training course and are negotiated with you.

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