Dr. Sonia C.
I have been working for the health industry, In-vitro diagnostic and medical devices for over 20 years, mainly at R&D positions and alw...
I am an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Cla...
Bioengineer passionate about medical devices but even more loves to build meaningful, evidence-based relationships between medical devices and ...
* Expert knowledge on Medical Device, In-vitro Directive and Medical Device regulation in India * Qualified ISO Lead auditor, accomplished more...
We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We ha...
Juan M. C.
Juan M. Campos is a Medical Device professional with + 33 years of continued industry experience. His main areas of expertise include Quality A...
Hi, I have 12 years of experience in a multinational Pharmaceutical and Medical Device company as a QA/RA manager. My Specialties -Experience...
Medical device professional with strong background in single use disposables, reusable medical devices(Class I, Class II and Class III) . Broad...
5 years experience as an Quality Assurance professional.I have a broad background, topics include: - ISO 13485:2016 - 21 CFR 820 - ISO 14971, ...
A proactive and result-oriented medical device professional with over 25 years of experience in QMS Systems and Regulatory Affairs compliance. ...
20+ years of QMS experience, ISO 9001 Lead Auditor, ISO 14001, ISO 13485. Heading currently a team of MDR consultant in Germany and providing M...
Product Design - Design based on expertise from the manufacturing environment, we support engineering teams by providing guidance on best prac...
An aspirational mind whose main interest is to pursue a career and advance in Regulatory Affairs and Quality Assurance, become part of an este...
Medical devices professional with more than 25 years' experience in senior management positions in early stage medical device companies. A...
Over 35 years of broad experience as Engineering professional…Medical Device Product Regulatory Requirements, Product Design, Project Managemen...
I have Experience in ISO 13485, ISO 9001, Quality management system, MDF preparation under the MDR rule 2017
Regulatory submission to Health Authority, GDPMD, QMS, ISO 13485, GDP, Post market surveillance and audits.
Experienced in Medical device Post Market Surveillance (PMS) and process improvement. Familiarity with USFDA (21CFR Part 820, 806 and 803), QMS...
Kolabtree is the leading online marketplace for ISO 13485 consultants. Post your project, get bids, and hire an ISO 13485 expert.
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What Is an ISO 13485 Consultant?
An ISO 13485 consultant is a medical device expert who helps organizations meet specific quality management requirements, particularly in terms of fulfilling regulatory requirements related to medical device manufacturing, design, safety and market launch.
What Does an ISO 13485 Consultant Do?
An ISO 13485 consultant comes armed with deep knowledge on medical device quality management requirements, aligning these to what external parties such as certification bodies use for their judging and auditing purposes.
The expert’s recommendations help medical device companies ensure that their product meets these specific requirements across the supply chain, such as production, design and installation. This also extends to regulatory and compliance requirements, such as risk management and safety expectations.
Qualifications for an ISO 13485 Consultant
ISO 13485 experts typically have niche expertise and knowledge on the intricacies of medical device design certifications and process, as well as a working knowledge of how and when these requirements are updated. This involves,
- Intense training and vast experience in manufacturing process systems
- Auditing strategies and compliance knowledge and related certifications
- Thorough understanding of quality management systems, risk management and medical device efficiency
Benefits of Hiring Freelance ISO 13485 Consultants
Considering quality management is a periodic requirement for medical device manufacturers, hiring an on-demand ISO 13485 consultant makes a lot of financial and strategic sense.
These freelance experts are typically highly qualified, and possess past experience from high-impact projects. This also enables organizations to hire the best ISO 13485 expert irrespective of location, since freelance platforms have independent scientists and consultants registered across the globe.
Cost of Hiring an ISO 13485 Consultant
ISO 13485 consultants charge according to a wide range of factors, such as scope of the project, duration of the consultation required, and the market impact of the medical device in question.
Since niche factors such as safety, design and compliance are hard to define tangibly, consulting these experts on-demand can be a more feasible option throughout the supp[ly chain.
On Kolabtree, you can hire freelance ISO 13485 consultants for as low as $35/hour, with more experienced freelancers charging up to $200/hour.
How to Post a Project to Hire ISO 13485 Experts
Before posting a project, you need to decide the following criteria in terms of hiring a freelance ISO 13485 expert,
- The particular quality management, medical device design or regulatory compliance process you’re hiring for
- The skills and experience you want the ISO 13485 consultant to possess
- The budget and duration of the project
Now, post a project on Kolabtree detailing these requirements step by step, which will ensure you receive quality proposals from the best independent ISO 13485 experts around the world. Alternatively, you can directly browse through the best experts available for consultation, and pick one that suits your requirements.