Bridging the gap between Regulatory, Quality & Engineering.
Technical compliance consulting for medical devices. Design control, risk management & DHF remediation. FDA, EU MDR and Health Canada compliant documentation.
MDR
REMEDIATION
Gap analysis, review, and remediation of DHF and risk files for compliance with the Medical Device Regulation (EU) 2017/745 for the European market.
DESIGN CONTROL & RISK MANAGEMENT
Design control and risk management process and documentation for new or existing products, from startups to multinationals.
Whether you have established quality systems and a clear plan or are just getting started, Ogma can help. Services include review, planning, training, and implementation.
PRODUCT DOCUMENTATION ASSESSMENT
Review & gap analysis of product documentation to assess your DHF, DMR and risk files for :
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Audit preparation.
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CAPA / audit response.
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Internal audits.
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Mergers & acquisitions.
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Management review.
FLEXIBLE PROJECT STRUCTURE
Ogma can adapt to different project structures to suit your needs. Ogma can accompany your internal teams with the appropriate level of integration to suit the situation.
Ogma can work to suit your needs:
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directly for the end client;
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as a sub-contractor;
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or through agencies.
Ogma is always looking for challenging projects, large or small, straightforward or complex.
EXPERTISE
Focussed exclusively on design control and risk management for medical devices.
Ogma has expertise in design control, V&V (verificaion and validation, and risk management across a wide range of medical products. Systems development, remediation planning, documentation preparation, and DHF review. Principle consultant Ewan MacKenzie has over 20 years of experience in the design and manufacture of medical devices including several patents.
COMPANY
Ogma Consulting is located in Quebec City, Canada. Ogma specializes in technical compliance for medical devices, including design control and risk management documentation. Owner and founder Ewan MacKenzie, P.Eng. is a mechanical engineer with over 20 years of medical device design control and risk management experience.
Ewan’s career has included medical device manufacturing, new product design and DHF remediation in the U.K., Canada, and the United States. He has experience in many product areas including wound care, surgical tools, electro-mechanical equipment, IVD equipment, respiratory diagnostic equipment, sterilizers, critical care consumables, dental products, ostomy products and others. He has worked with many regulations and standards including MDD, MDR, FDA 21CFR820, ISO 13485, ISO 14971, IEC 61010-1, IEC 62366-1, ISO 11607-1, and many more.
All services are available in English or French. To find out how Ogma can help your company with medical device design control and risk management, please get in touch.