Medical Devices Consulting
Medical Devices Consulting
We support companies and medical professionals to create value through our new developments, by offering marketing strategies to meet market needs, by optimizing processes and by simplifying your regulatory affairs. This allows companies to avoid internal staff increase which, in turn, enables them to focus investment on their core business and to direct their attention to their key commercial interests.
Over 30 years of experience in the medical devices industry make it possible for us to generate productive communication among the commercial area, engineering, medical professionals, health institutions, health insurance companies and regulatory agencies. Such flow of communication leads your product/service to provide the experience- in terms of time, cost and quality- your customer expects to get.
We generate new value that allows you to take advantage of your market opportunities to meet your business goals.
→ Strategy Implementation through Projects: We collaborate with SMEs to understand their strategic needs, evaluate projects based on objectives, measure risks and control them through standardized Project Management processes.
→ Multidisciplinary Innovation: We highlight the points of view of all players in the value chain, to generate a requirements plan according to the challenges that the product / service will face in its life cycle.
→ Change Management: We develop processes to overcome "glass ceiling" in the evolution of the business. We implement Design Thinking technique, evaluating new ideas in terms of their desirability, technical feasibility and commercial viability. We encourage creativity in the work team to facilitate the creation of new sources of value.
→ Customer Centered Design: We accompany SMEs in optimizing their competitive strategy through the study and understanding of customer needs and reducing the gap between expectation and experience.
Design and Engineering
We support your idea from its conception to the full accomplishment of its commercial goals.
→ Idea Realization: We integrate a set of disciplines that enable us to offer you the opportunity to efficiently develop your idea in time, cost and quality. Our service includes project management, marketing strategy, initial concept development, technical and operational feasibility study, design and engineering, CAD-CAM, rapid prototyping, testing and validation, intellectual property protection, regulatory management and supply chain management.
→ Optimization of the Innovation Process: From the beginning of the project, we follow the Quality Management guidelines established by ISO 13485, documenting each engineering decision in the Desing History File, performing control and change management, thus facilitating the subsequent preparation of the Medical Device Technical File, its revision and validation for commercialization.
→ User Experience: We implement ISO / IEC 62366 and Industrial Design Usability standards, generating product use interfaces that allow efficient behavior in achieving the desired task in its real conditions of use.
Quality and Regulatory Requirements
We guarantee the safety and efficacy of your medical product and compliance with regulatory requirements.
→ Quality Management: We design and implement your system according to ISO 9001 and ISO 13485, complying with the SMART principles and developing the specific documentation. We audit your quality management system and collaborate with the development of your suppliers.
→ Risk Management Plan: We design and implement complying with the requirements of ISO 14971. We identify hazards and risks in products and manufacturing processes and implement measures for risk mitigation and remediation.
→ Good Manufacturing Practices: We develop and implement your GMP system according to the requirements of ANMAT Disposition 3266/13, FDA and European Community.
→ Essential Safety and Efficacy Requirements: We determine the requirements according to the information coming from the Risk Management Plan and the different engineering areas. We make the documentation according to the applicable regulatory requirements.
→ Medical Products Registration: We collaborate in the preparation of your Design Registrations and Technical Files (Device Master File) according to national and international regulatory requirements (ANMAT, FDA, Europe).
After several months of joint work between those responsible for the Quality and Regulatory area of Mechanized Gabriel S.A. and specialists of KEYMED Devices in the comprehensive review and fine-tuning of their Quality... Read More
Diagnosis: Severe scoliosis with angulation greater than 50 ° and restrictive pulmonary alteration. Objective: 3D surgical planning (VSP) to improve angulation and restrictive pulmonary process. Development: from a CT performed according to a specific protocol... Read More
We work together with medical teams to generate anatomical models of specific patients that facilitate the study of complex cases such as tumor cases, congenital malformations, complex osteotomies, scoliosis, etc. From CT, MRI and X-rays... Read More
Diagnosis: segmental defect in acetabulum + combined cavitary type Paprosky IIIB. Objective: restitution of normal joint function, development of customized acetabular reinforcement, restitution of anatomical axis, rotation center and anteversion. Development: virtual surgical planning, 3d... Read More
Strategic analysis. Costs. ANMAT certification as Manufacturer according to disp.2319/02. New Knee Implant Design
REGDESK – Philadelphia, USA
Applicability of electronic Instructions for Use (eIFUs) in the Argentine regulatory system. Study of mandatory requirements requested by the Argentine Regulatory Authority (ANMAT).
Mecanizados Gabriel S.A.
Development of Design History File. Risk Analysis. Implantable medical device testing. Good manufacturing practice system update
The Faculty of Engineering at University of Buenos Aires will start on October 20 a Postgraduate Complementation Course on Biomaterials in Medical Devices. The course, which is theoretical and practical, will have a total duration... Read More
“…The Invisalign orthodontics are made from bio-compatible polyurethane resin using 3D Systems’ Stereolithography (SLA) 3D printers…” 3dprintingindustry.com How 3D printing has changed dentistry, a billion dollar opportunity Read More
From July 18, 2017, the HELENA system for the Electronic Registration of Class I and II Medical Products and its amendments will enter into force, within the framework of the new regulations (Order 5706/17). Read... Read More
Finally, the new Directives for Medical Devices and In Vitro Diagnostic Products (IVD) were published in the Official Journal of the European Union. Its entry into force will be 20 days after its publication (date... Read More
On 17 and 24 August, a training workshop will be held (face-to-face or virtual) for staff from establishments reached by the regulatory framework of the National Administration of Food, Drugs and Medical Products (ANMAT). For... Read More
Development of customized solutions: Applications. Regulatory Aspect. 3D Technologies. Project management. Tuesday, August 08, 7:15 p.m. Summary of the presentation The generation of solutions in medical devices has historically been conditioned by the limitations of... Read More
Keymed Devices will attend the Jacob K. Javits Convention Center in New York, NY at MD & M EAST 2017, which is the largest source of suppliers in the medical device industry connecting production contractors... Read More
Keymed Devices will attend in Pittsburgh Pennsylvania USA, the world’s most relevant event on additive manufacturing, 3d printing and bio-printing. There we will find the latest technologies ranging from the manufacture of surgical devices and... Read More
Head of Quality and Regulatory Requirements
Industrial Engineer. Pablo has over 30 years of experience in the field of medical devices and implantable sterile medical devices as well as in the area of medical device design, manufacturing engineering, quality management systems implementation (ISO 9001, ISO 13485) and Good Manufacturing Practice. His expertise includes risk analysis and management (ISO 14971) as well as safety and efficacy assessment.
Professor of Endoprosthesis I and II at the Rehabilitation Science Institute (San Martin National University- Buenos Aires.) and professor of Biomechanics at ITBA (Buenos Aires Technological Institute) at Bioengineering course as well as a member of the Argentine Standards and Certification Institute (IRAM) - Surgical Implants subcommittee and Medical Products and Devices Use subcommittee. He is an evaluating member of the Argentine Sector Funds (FONARSEC) technical projects- Scientific Promotion National Agency (ANPCYT)- Argentine Science and Technology Ministry.
Head of Design and Engineering
Industrial Designer and PMI certified Project Manager, Ezequiel has worked in the field of medical devices design for over 17 years. His experience encompasses I+D, product engineering, quality management, regulatory management, marketing and commercialization.
Ezequiel is a Design Thinking lecturer at the renowned ITBA (Buenos Aires Technological Institute), a Project Management lecturer at UTN (National Technological University) in the Industrial Organization major and at UNER (Entre Ríos University) at the Bioengineering course.
He also lectures in Spine Prosthesis at ITBA at the Bioengineering course.
Jorge J. Gallo
Graduated at the University of Buenos Aires. Aires in 1968, in the courses of Electromechanical Engineering in the Electronic and Mechanics orientations.
He has attended advanced courses on Design Reliability and Product Development and Processes sponsored by Ford Motor in Argentina, Brazil and USA, where he worked in the Product Engineering Office, as Supervisor of the Reliability Section Of Systems and Suppliers, during 19 years, collaborating in that interval of time in the validations of the new designs faced by that company and in the development of the suppliers associated with them.
For 7 years he led Mirgor S.A. (Valeo Thermic) the Departments of Quality Engineering, Development Engineering, Quality Development, including also in the field of Purchasing Engineering the development of new suppliers, and the advice of existing ones in processes of continuous improvement of its level Quality and productivity.
He has produced and published numerous papers on the reliability of products and their manufacturing processes. He taught courses and conferences of the specialty in different National and International Institutes and in the main universities of Argentina.
During thirty years of academic experience, he was Deputy Dean and Academic Secretary of the Pacheco Regional Technological University and he is a full professor of the subjects "Automatic Control Systems", "Quality Engineering", "Mechanical Design", "Final Project" Machines and Electrical Installations ". He was also holder of the subject "Industrial Quality" of the Master in Business Administration of the Universidad Católica Argentina. In the University of Belgrano was professor in the Master in Engineering of Motor Vehicles "in the matter" Engineering of Quality ". In the Regional Faculties of the Universidad Tecnológica Nacional (UTN) Mendoza, Resistencia and Concepción del Uruguay, he was professor in the Master in Quality in the subjects "Reliability" and "Design of Experiments". In the Regional Faculty Pacheco was also the director of the Master's Degree in Quality Engineering. He was director and jury of thesis of numerous theses of masters in quality and was the consultant in subjects of quality of the Commission of Postgraduate of the Academic Secretary of the Rectorate of the UTN. He delivered training courses to the auditing staff of the Norwegian certifying body DNV in techniques of statistical and metrological domain of industrial processes.
As a consultant of companies in matters related to the management of the quality of processes within the framework of the norms ISO 9001, QS - 9000, EAQF 94, TS 16.949, ISO 140001, HACCP, OHSAS 18001, ISO 13.485 and CE marked according to the European Directive 93/42 has advised 197 national and international companies which have obtained 165 certifications of different nature. He is a specialist in risk management for the design and manufacture of medical devices and in the statistical determination of their useful life and suitability for use according to the latest requirements of the DNV-GL Notified Body.