Providing Regulatory and Quality compliance to the medical device industry

Peter Rose BSc(Hons) CBiol MSB ACQI MTOPRA - Managing Director
Peter assists medical device manufacturers with their ISO 9001 and ISO 13485 quality systems, microbiological audits & reviews, technical files and CE marking. He is a lead auditor and a microbiologist. Peter's background includes roles include Quality Management, Sterilisation, Cleanroom Consultancy, Quality Systems Consultancy and Laboratory Management. Sectors and device type experience is wide ranging encompassing Class I, IIa, IIb and III devices. Peter worked with amongst other Fresenius, Sterigenics, and Isotron.

With 16 years experience in the medical device sector, Peter has a wealth of knowledge in quality and regulatory affairs. He has extensive experience in regulatory audits working with various European Notified Bodies, Canadian CMDCAS audits and US FDA Inspections. Peter combines his practical approach to solutions and an appreciation of business finance, to assist businesses through the regulatory maze in a very practical and constructive way.

Chris Shenton MCQI MRSC - Medical Device Regulatory Specialist
Chris has over 21 years experience in Medical Devices having previously worked at Wesley-Jessen, Profile Respiratory Systems, KCI Medical Products and as RA/QA Manager at Medical Innovations Group. A lead auditor and a Member of the CQI, Chris is an outstanding auditor who enjoys auditing and assisting companies with continual improvement. Chris has experience of a wide range of products both sterile and non sterile and submissions to USA, Canada, Japan, Australia, New Zealand, Russia, Thailand, Africa, South America and of course the EU.

Specialist areas for Chris include auditing, technical files, risk management and medical electrical equipment (Electromechnical). Additionally NEBOSH qualified and an ISO 14001 (Environmental Management Systems) auditor.

Malcolm Pinfold MA, AMIMechE - Medical Device Regulatory Specialist
Joining High Edge from the Notified Body British Standards Institution (BSI), Malcolm's background is in engineering where he graduated with a First Class Honours degree from Cambridge University. He is a qualified lead assessor for ISO 9001 and ISO 13485, as well as being highly experienced in developing and successfully implementing high tech engineering solutions for medical devices, pharmaceutical manufacture, robotics, laser technology, vision systems and machine controls.

Malcolm's experience at BSI means that he brings to High Edge an insider's view of managing all aspects of compliance to the Medical Devices Directive and CE Marking for medical device manufacturers. Prior to BSI, he worked with a number of leading manufacturers and pharmaceutical companies, including ApaTech, Ranier Technology and GlaxoSmithKline. Malcolm has good working knowledge of several languages including: French, Spanish, Italian and German.

Lee Simpson BSc(Hons), CBiol, MSB, ACQI - Medical Device Sterile Products Specialist
Lee is degree qualified Microbiologist with experience of a variety of sterilisation methods including, Gamma, E-beam, EtO, Steam, dry heat and aseptic fill, contamination control and cleanrooms. Lee is also a lead auditor and an experienced Quality and Regulatory Manager. With expertise of all classes of medical devices, Lee has authored and submitted fourteen 510(k)s to the USA, and also created submissions to Saudi. Lee has worked in both Pharmaceutical and Medical Device companies and has a broad experience of a wide range of medical devices including drug device combination products and software.

Lee has previously worked for Lantor UK, Ashton Pharmaceuticals, Becton & Dickenson, Miza Pharmaceuticals and Aventis and held the positions of RA/QA Manager, QA/RC Specialist, QA Manager, Company Microbiologist and QA Manager.

Lois Smart - Medical Device Regulatory Specialist (US)
Lois has worked and consulted in the Medical Device arena for 22 years having been employed at, amongst others, Angiotech, Johnson & Johnson, National Medical Care, Quill Medical and Davis & Geck. Prior to her medical devices career, Lois was a member of the United States Marine Corps.

Based in North Carolina, USA, Lois provides regulatory and quality management solutions to the medical device industry, specialising in technical files / design dossiers for CE Marking, 510k submissions for US clearances and IDEs for clinical trials. She is well versed with compliance to Quality Systems ISO 13485, ISO 9001 and of course the FDA QSRs. Lois is very experienced in dealing with FDA inspections and Form 483 responses on behalf of clients.

Lois acts as the liaison point with the FDA on behalf of High Edge Consulting's customers and specifically can be the Applicant Correspondent during US regulatory submissions. Being based in the USA with her local contacts Lois often receives updates and insights into FDA news and practices before they hit the mainstream Medical Device press here in the UK.

Louisa Rose BA (Hons) - Finance and Operations Director
Starting with a career in Housing Management and working for both Local Authorities and Housing Associations, Louisa's skills were channelled as a housing consultant for a major software company. During her 6½ years with Comino PLC (who were acquired by Civica) she played a key role in the development, implementation and pre sales support for the company's suite of software products as a product specialist.

After a brief career break to spend time bringing up the new arrivals in her family, Louisa joined High Edge Consulting to support and take a leading role in growing the company. She is a board member and oversees all the finances of the company together with ensuring that the day to day operations of the business run smoothly. Utilising her project management skills, Louisa ensures projects are resourced and planned and she keeps projects moving and on track to agreed deadlines. She acts as the management representative of High Edge's own certified ISO 9001 quality and ISO 14001 environmental management system.

Dina Morton BA (Hons) - Sales, Marketing & PR Manager
Dina's focus is to respond to our customer enquiries and provide the information you need about High Edge's specialist consultancy services. Holding a pivotal co-ordination role between sales, marketing and PR, Dina utilises her nine years marketing experience in the Business-to-Business space to drive High Edge forwards, forging strong and highly responsive communications with our customers.

Dina joins High Edge from a London-based marketing agency where she worked with Evonik, Siemens and Pitney Bowes. With client care and clear communication at the core of her role, Dina will usually be your first point of contact with High Edge Consulting.

Ruth Crowston - Contracts and Office Administrator
Starting with the company in early 2011, Ruth is High Edge's Contracts and Office Administrator. Ruth is responsible for contract administration starting from processing purchase orders that are received to monitoring service delivery of those contracts. Utilising her administration skills, Ruth monitors and reports on the company's KPI's and manages our customer satisfaction surveys. In addition, Ruth takes bookings for public training courses and carries out many other office administrative duties.

Ruth joined High Edge from the British Geological Survey where she had worked for 9 years in the library.