High Edge Consulting

The full title is: BS EN ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for regulatory purposes. The standard defines the quality management system for medical device manufactures. ISO 13484 is based on ISO 9001 and shares a very high degree of commonality with it. While ISO 9001 can be used for any business, ISO 13485 is specific to medical device manufacturers and mandates additional procedures to ISO 9001 that meet customer and regulatory requirements applicable to medical devices.Â ISO 13485 is a stand alone quality system for medical device manufacturers.

In the medical devices arena there are 3 principal EU directives; these are the Medical Devices Directive 93/42/EEC, the In Vitro Diagnostics Directive 98/79/EC and the Active Implantable Medical Devices Directive 90/385/EEC. All these directives require a Quality Management System as part of their Essential Requirements. Â It is not mandatory for medical device manufacturers to have ISO 13485 certification, however ISO 13485 is a harmonised standard, meaning that compliance with it will provide a presumption of conformity with the essential requirements of the relevant directive.

Due to the benefits of adopting a harmonised standard approach, the vast majority of medical device manufacturers in the EU market implement a formal certificated ISO 13485 Quality Management System.

Whilst ISO 13485 is not a mandatory requirement for medical device manufacturers, you are still required to have a quality management system that satisfies all the essential requirements of the EU directives governing medical devices. In our experience when your quality system is audited the auditor will work to an ISO 13485 checklist (because this is the more normal route). High Edge Consulting Ltd would normally recommend you implement a formal ISO 13485 quality management system. If you are intending to sell your medical devices to Canada, it is essential for you to have a certified ISO 13485 quality system. Furthermore your ISO 13485 certificate must have been granted by a SCC accredited registrar. Not all notified bodies have such registrars. Other markets have their own requirements for quality management systems which may or may not include ISO 13485. Please contact us for specific information.

Quality systems

CE Marking
Yes, providing you are able to interpret the ISO 13485 standard and have a good understanding of the medical device industry. Medical Devices are highly regulated because patient safety is paramount. A mistake could cost lives. Auditors would expect you to have a sound knowledge in Medical Devices and be able to substantiate any claims that you make.

Quality systems

CE Marking

It is a legal requirement to have a medical device CE marked if it is to be marketed and sold in the EU. Whilst you see CE marks on many items such as electrical items, toys, books and so on, they are all CE marked by applying the applicable â€˜new approachâ€™ directive to them. CE marking denotes your device has a declaration of conformity, which you achieve by complying with the relevant directive. There are three directives applicable to medical devices. Your Notified Body would normally award your ISO 13485 certificate simultaneously with a conformity assessment (CE Marking) audit.

Quality systems

CE Marking

Your Quality Management System (QMS) must be implemented and then audited by any European Union (EU) Notified Body. Whilst you can approach any EU Notified Body it may be more sensible to approach one that is based in the UK and therefore UKAS accredited. You may also want to choose a Notified Body with expertise in your niche field. If required High Edge Consulting Ltd can help you choose a suitable Notified Body to suit your medical devices.

Quality systems

For medical devices, there are three directives: Directive of Active Implantable Medical Devices (90/385/EEC), the Medical Devices Directive (93/42/EEC), and the Directive of In Vitro Diagnostic Medical Devices (98/79/EC). If you are selling a medical device in the EU it must be CE marked which is achieved by implementing the applicable directive to your product. For further information on the medical device directives please see our Regulatory Affairs page.

At High Edge Consulting we have a thorough knowledge and understanding of ISO 13485. Our consultants have practical hands on experience of working in the medical device field and ISO 13485. We recognise that medical devices is a specialist area and therefore requires consultants who have specialised in this area too. Implementing a quality management system for medical device manufacturers and suppliers to the medical device industry requires not only theoretical knowledge of ISO 13485 but practical experience too. Consultants who truly fulfil this specialism are difficult to find but you can be rest assured that High Edge Consulting has the calibre of consultant you need.

Our experience of implementing ISO 13485 is extensive, just look at our testimonials to see how happy our customers are. Many testimonials are from medical device manufactures and their suppliers, ranging from SMEs to large multi national companies. What ever your size, you will find the services we offer are beneficial to you. Look at the benefits of using High Edge Consulting, High Edge Consulting can offer your business and your staff support at any time in the implementation of ISO 13485 or we can implement the whole system on your behalf.

Once you have your ISO 13485 certificate, the work does not stop there. High Edge Consulting offers maintenance contracts to assist you with maintaining your quality system. Using our knowledge and expertise, we can keep your quality system working for you and carry out any maintenance work quickly and effectively. Our maintenance contracts start from with a requirement of 6 days per year and rise to 2 or 3 days per week. We recognise that you may require more consultancy at the beginning of the contract and less as time goes on. We invoice maintenance contracts on a monthly basis so the cost of front end loading a contract is paid for over the whole year.Â Our maintenance contracts are flexible and can be tailored to you requirements. They can also include regulatory affairs, contamination control & microbiology, sterilisation and validation consultancy. A maintenance contract set up for 12 days per year for Quality System maintenance may end up being 8 days quality system maintenance, 2 days regulatory affairs and 2 days sterilisation consultancy because your needs and demands change. Our flexible approach has been a significant factor in customers selecting to work with High Edge Consulting. Our maintenance contracts are for a minimum of 12 months and then month to month thereafter. All maintenance contracts are payable monthly spreading the costs over a year. If you require any additional days for specific tasks these can be ordered at any time.

Your ISO 13485 quality system is up and running. Someone in the organisation has the responsibility for the day to day running and maintenance of your system or it is outsourced through a maintenance contract. Frequently the cost of employing a quality professional is prohibitive especially to SMEs and therefore the responsibility tends to lie with an existing member of staff. Your member of staff may maintain your quality system satisfactory but they may require regular support whether it be for reassurance they are doing something right, request for clarification on certain points, assistance with the annual management review, regular impartial internal audits or support during the compliance audit. High Edge Consulting offers a range of Service Agreements to provide support to your company and staff responsible for your quality system. Take a look at our comparison chart to see the service agreements that are available. Our service agreements are for a minimum of 12 months and then month to month thereafter. All service agreements are payable monthly spreading the costs over a year. If you require any additional days for specific tasks, these can be ordered at any time.

Internal audits are a part of any ISO 13485 quality system. Some organisations fall behind their internal audit schedule and catch up before their certification body re-audits them. Internal audits may be carried out by an independent third party who can audit regularly according to your audit schedule and be impartial in their view as to whether or not the quality system is being adhered to. Supplier audits (all so known as vendor audits) are frequently seen as an inconvenience. They may involve taking a valuable member of staff time to travel to the supplier carry out the audit and write the report. In addition to this, the person carrying out the audit must learn how to audit, complete the audit report and make recommendations. High Edge Consulting can provide you with a professional lead auditor that can take the work demands of audits from you. Your lead auditor will arrange a list of dates to coincide with your internal and supplier audit schedules so you know they will be kept on track. If required we can also arrange for our consultant to be present at your third party audits (certification and surveillance audits).

Training of staff is essential to any implementation of ISO 13485. Even staff who have worked with ISO 13485 need to have regular refresher training. Our training courses whilst general in nature are tailored to your business needs using real examples of your business. Click here to see the standard training courses we offer.

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