Profile Summary
Pranay V.
With more than 5+ years of experience in MEDICAL DEVICE industry, I have developed many devices, regulations, SOP's as per quality standard...
Jacqueline V.
Registered healthcare professional with 16 years of clinical experience in academic hospitals and clinical research. Trained in Clinical Evalua...
Marin L.
Leading medical strategy in matrix-based global environment and providing scientific and business consultation to a local and global pharmaceut...
Valter G.
Animal technician/caregiver in health research for 7 years. Freelance translator and proofreader since 2017. Language pairs: Portuguese<->...
Arjun L.
I have a blend of experience in clinical medicine, pharmaceutical industry and medical device industry....As a medical doctor, I work on infectious diseases, pulmonary and critical care and public health....
Peter O.
Product experience includes Class 1, 2 and 3 devices: external defibrillators, AEDs, infusion pumps, patient monitors, image guidance, ventilat...
Viktoria K.
I am an independent clinical research professional with 14 years experiences in the sector. My expert area is clinical trial protocol content r...
QUYNH N.
EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...
Katrina L.
I am a biomedical scientist with a broad range of experience from academia, industry, and government. - Self-starter with project management an...
Neethu A.
Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...
Waqas A.
PROFESSIONAL PROFILE: A Regulatory Affairs/ Quality Operations Professional with thirteen years drug development experience (Pharmaceutical), w...
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Obuchinezia A.
UK-based, working across the UK and Brazil. I help biotech and healthtech teams integrate AI and real-world data into clinical development, ena...
ADNAN A.
20 years in Medical Devices, QA. RA, Validation for all Classifications of Medical Devices. MDR. IVDR expertise, with Software as a Medical Dev...
Andrew B.
Technical writer with 3 years’ experience executing clinical-regulatory documentation and demonstrated knowledge of EU MDR, clinical evaluation...
Dr. Loleta R.
Seasoned clinician innovator (MD, MBA) and data-driven strategist with unique healthcare and business acumen. Proficient in leading in-depth ma...
Mariem R.
I have 15 years of experience in the field of Public Health and Clinical Research in several positions: coordination, monitoring, project man...
Athar A.
Globally experienced Product Executive with expertise in Digital Health and IoT medical devices using AI/ML, AR and launch in global markets. I...
Neha S.
Strongly reliable and focused Regulatory Affairs Specialist with great depth and breadth of experience in medical device regulation and reporti...
Karthickeyan V.
I'm an Engineering graduate having around 7 yrs experience with expert knowledge in EUMDR.
Elaine S.
Extensive experience in orthopedic biomedical research, data analysis, manuscript writing and editing, CEP/CER writing for EU MDR, and systemat...
Chunnan C.
An experienced professional with 20 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations;...
Ali H.
Consulting services including application of IEC/EN 60601-1, IEC 62304, IEC 62366, ISO 14971. Project Management - Medical Devices Compliance. ...
Manoj Krishnaa S.
I help clients to define the medical device documents and align with Regulatory aspects. Works with small business owners and entrepreneurs. T...
William T.
Experienced Technical Writer and Laboratory Scientist adept at managing and executing multifaceted projects within stringent timelines. Profici...
Kripa G.
Experienced Public Health professional with >14 years of experience across working for healthcare, skilling and educational sectors in I...
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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You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.
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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.