Profile Summary
Dr. Muhammad M.
"Hello and welcome to my freelance profile! I am a scientific writer and product development specialist with several years of experience ...
Dr. Dilip B.
I am the holder of highly prestigious Tier 1 Exceptional Talent Visa and endorsed as such by the Royal Academy of Engineering in the fields of ...
Dr. Diksha V.
I am a doctorate in life sciences with an experience of over 9 years in the academic and corporate sector. I have managed projects focusing on...
Dr. Muhammad H.
It's me Dr.Hamdan, professionally computational biologist. My profession, not only professionally, but my passion is to interact with globa...
An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10...
Sundeep A.
A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...
Dr. Ahram Q.
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
Dr. Hafsa I.
Medical Device Production Manager with 5 years of experience in device development - Technical file - Design File - Procurement - Technology De...
Dr. Sandeep P.
Ph.D. in Chemistry having a total of 14+ years of experience in the pharmaceutical industry, expertise in the regulatory intelligence of pharma...
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Dr. Imen F.
PHD pharmacist, with more than 5 years of experience in Quality Assurance (QA) and Regulatory Affairs (RA). My experience enables me to help yo...
Dr. Paolo S.
Doctor in Engineering specialised in medical devices research and development. Focused on validation and verification of development processes ...
Dr. Arinzechukwu U.
I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...
Dr. Hrishikesh G.
Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...
Having experience in medical device regulatory affairs, EUMDR, USFDA 510K, ISO 14971, ISO 13485
Lakshman Prakash B.
Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qua...
Vision-driven executive with over 25 years of demonstrated leadership in the pharmaceuticals industry. Proven track record of driving bold init...
I am a process and product development commercialization consultant and project manager with an automation and mechanical engineering backgroun...
Stephane G.
R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...
Dr. Sathesh Kumar A.
Fourteen years of R&D, Regulatory and Medical writing experience in various disciplines across In-vitro diagnostics, medical device regulat...
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. 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...
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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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.
