Dr. Ahram Q.
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
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...
Dr. Muhammad M.
Hello and welcome to my freelance profile! I am an accomplished Data-Driven Scientist with extensive expertise in comprehensive data analysis a...
Dr. Vera M.
Providing leadership and strategic direction in Drug/Medical Device Development and Quality assurance to meet the new Industry challenges Leade...
Nida A.
An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR 2017/74...
Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Su...
Sundeep A.
A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...
Rudra P.
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...
Dr. Hafsa I.
Medical Device Production Manager with 5 years of experience in device development - Technical file - Design File - Procurement - Technology De...
Dr. Sharma P.
Implementing ISO13485 and ISO9001 quality systems for various market requirements building compliant and conformant QMS and product regulatory ...
Minh Tuan T.
Regulatory and Clinical Affairs Maintained strong customer relations, providing exceptional on-site technical, clinical, and sales support to o...
Biomedical E.
I am Umair Ahmed, a seasoned Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical devic...
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 11 years in the academic and corporate sector. I have managed projects focusing o...
David P.
I am a process and product development commercialization consultant and project manager with an automation and mechanical engineering backgroun...
Madhu S.
Over 10 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, ...
César Daniel B.
- Specialist in hydrocarbon gas chromatography using Gas Chromatographs with Flame Ionization Detection (GC-FID) and with Selective Detection b...
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. Pavan M.
I have a doctorate in Biological Sciences with expertise in lifestyle-associated metabolic complications such as obesity, diabetes, and liver ...
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. Murtaza Najabat A.
I am a biomedical engineer with over 20 years of experience in medical device development and healthcare technology. Apart from academia, I hav...
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. 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...
Dr. Trinadh Venkata Satish T.
Experienced Research Scientist with a Ph.D. and over 20+ years of demonstrated history of working in the areas of Tissue Engineering, Infectiou...
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...
Kolabtree is the leading online marketplace for ISO 13485 consultants. Post your project, get bids, and hire an ISO 13485 expert.
We take several measures to help you work with full confidence and peace of mind.
Keep your project private
Restrict who can see your project and send you proposals. Invite only specific freelancers to view your project.
NDAs and IP protection
Our T&C include a default confidentiality clause that protects your IP and NDA for added protection before disclosing project details.
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.
Contact experts directly
Speak directly with freelancers and explain your requirements.
100% satisfaction guaranteed
You have to approve the deliverables only if quality meets your expectations. If you arn’t happy, we’ll refund your money.
Project Management
Keep track of files and conversations in the user-friendly Workspace.
Flexible, secure payments
You can choose to pay either a fixed or an hourly fee based on your requirement.
-
Freelance ISO consultant required$550.00
-
Looking for ISO 13485 consulting services$400.00
Post your Project (Free)
Your project details are safe, secure and visible only to logged-in users.
Get Quotes & Choose Experts
Discuss your requirements in detail with the experts before accepting the final statement of work from Kolabtree.
Collaborate
Pre-pay for your project and work with the expert to get your desired output. Keep track of files and conversations in the user-friendly Workspace.
Job Done!
Approve the deliverables once you're satisfied with the job done.
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.