Profile Summary
Dr. Sarah C.
Consultant to the digital health & life sciences industry with a strong research background in early stage drug discovery. I have extensive...
Dr. Waqar L.
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
Dr. Imen S.
monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set...
Dr. Hatem D.
Statistician and Data Analyst | Expert in Medical device ,Beauty and pharmaceutical products (Filler -Botox- PRP -etc) , with 15+ years of expe...
Dr. Vishal M.
Technology focused accomplished Material Scientist with research and professional expertise in developing innovative materials solutions. As a ...
Dr. Riccardo C.
Former researcher in Nanotechnology, Life Science & AI. Actually working as specialist in medical devices
Dr. Bogdan M.
I am an PhD Chemical engineer with proven experience in quality assurance and regulatory affairs. Currently I am the J. Manager Global Regulato...
Dr. Nadeem A.
• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with t...
Dr. Eric L.
With a strong scientific background, I bring extensive expertise in medical device development's regulatory and quality aspects. As an acco...
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...
Dr. Derek C.
I completed my PhD in Chemical Biology and have previously worked in the medical device, pharmaceutical, and in vitro diagnostics industries.
Denise A.
I am an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Cla...
Selina B.
Medical Communications Consultant -Writing Clinical Evaluation Reports (CER) for medical device manufacturers -Preparation of clinical reports ...
Sonali S.
Having experience in medical device regulatory affairs, EUMDR, USFDA 510K, ISO 14971, ISO 13485
Beliz A.
Bioengineer passionate about medical devices but even more loves to build meaningful, evidence-based relationships between medical devices and ...
Pradip F.
I am managing R & D project for in-vitro diagnostics, in-vitro drug screening, medical device, and vaccine development. I look into all as...
Amrita S.
Entrepreneur with over 10 years of experience in the healthcare and diagnostics industry. Proven track record in leading innovative point-of-ca...
Regulatory 1.
* Expert knowledge on Medical Device, In-vitro Directive and Medical Device regulation in India * Qualified ISO Lead auditor, accomplished more...
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...
Kavita S.
We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We ha...
Damla V.
Hi, I have almost 15 years of experience in a multinational Pharmaceutical and Medical Device company as a QA/RA manager. My Specialties -Exp...
Lakshman Prakash B.
Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qua...
Tarun S.
Medical device professional with strong background in single use disposables, reusable medical devices(Class I, Class II and Class III) . Broad...
Tarun P.
Vision-driven executive with over 25 years of demonstrated leadership in the pharmaceuticals industry. Proven track record of driving bold init...
Akhthar S.
Sr. Executive & Entrepreneur with experience in Biotech, SaaS Healthcare, Medical Devices, Biomaterials- Cellulose, fibers, starch, PHA, PB...
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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Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality and NDA clause.
You will receive detailed proposals directly from Kolabtree. These proposals will include a comprehensive Statement of Work (SOW), project fees, milestones, and deadlines.
You can choose to pay either a fixed or an hourly fee based on your scope of work. Pre-pay for the next milestone. You have to approve the deliverables only if the quality meets your expectations. If you arn’t happy, we’ll refund your money.
Kolabtree will share multiple quotations for your project. You have the freedom to accept the quote that aligns with your project requirement and budget. You can get in touch with us in case you want to discuss the fee.
Our T&C include a default confidentiality clause that protects your IP and NDA for added protection.
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Freelance ISO consultant required$550.00
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Looking for ISO 13485 consulting services$400.00
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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.
