Hire an ISO 13485 Consultant: Find ISO experts on Kolabtree

Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
MPhil in Bioinformatics
Pakistan

My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Dr. Hrishikesh G.

Over 30 years of experience commercializing medical devices for large, mid-size and early stage companies.
Create Project
★★★★★
☆☆☆☆☆
USD 125/hr
PhD in Electrical Engineering
United States

Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood...

★★★★★
☆☆☆☆☆
USD 125/hr
Contact3

Dr. Muhammad M.

Data-Driven Scientist Specializing in Comprehensive Data Analysis and Scientific Writing for Advanced Research Projects
Create Project
★★★★★
☆☆☆☆☆
USD 30/hr
PhD
Pakistan

Hello and welcome to my freelance profile! I am an accomplished Data-Driven Scientist with extensive expertise in comprehensive data analysis a...

★★★★★
☆☆☆☆☆
USD 30/hr
Contact3

Dr. Vera M.

Clinical Research - Drug & Medical Device development and regulatory compliance (GCP/GLP/ISO 13485) - Expert Consult...
Create Project
★★★★★
☆☆☆☆☆
USD 200/hr
Post-Doc
United States

Providing leadership and strategic direction in Drug/Medical Device Development and Quality assurance to meet the new Industry challenges Leade...

★★★★★
☆☆☆☆☆
USD 200/hr
Contact3

Nida A.

Experienced MDR and FDA certified CER/Technical File Writer with 7+ years of experience with multinational industries
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
Law (LLB Honours)
Pakistan

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...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Lisa R.

REGULATORY AFFAIRS - Medical Device - Biotech - Dietary Supplement - Pharma
Create Project
★★★★★
☆☆☆☆☆
USD 200/hr
Certificate of Regulatory Affairs , Dietary Supplements and NHP
Australia

Highly motivated Product Formulation Expert and Regulatory Affairs Expert in the following fields: Medical Devices ,Pharmaceuticals ,Dietary Su...

★★★★★
☆☆☆☆☆
USD 200/hr
Contact3

Sundeep A.

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management
Create Project
★★★★★
☆☆☆☆☆
USD 100/hr
Master of Technology - Quality Management
India

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...

★★★★★
☆☆☆☆☆
USD 100/hr
Contact3

Rudra P.

Group of Clinical Research Professionals (Project Manager, Biostatisticians, CRAs, Medical Writers, SAS Prgmers)
Create Project
★★★★★
☆☆☆☆☆
USD 70/hr
MS
India

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...

★★★★★
☆☆☆☆☆
USD 70/hr
Contact3

Dr. Hafsa I.

Medical Device Regulation (MDR) - BER - Technical File - CER - ISO13485 - Production manager - SOPs -
Create Project
★★★★★
☆☆☆☆☆
USD 35/hr
PhD Biomedical Sciences
Pakistan

Medical Device Production Manager with 5 years of experience in device development - Technical file - Design File - Procurement - Technology De...

★★★★★
☆☆☆☆☆
USD 35/hr
Contact3

Dr. Sharma P.

Highly skilled QA and RA certified lead auditor with diverse industry experience in more than 56 markets with UK's N...
Create Project
★★★★★
☆☆☆☆☆
USD 40/hr
M.Sc. (by Research) Biomedical Sciences
United Kingdom

Implementing ISO13485 and ISO9001 quality systems for various market requirements building compliant and conformant QMS and product regulatory ...

★★★★★
☆☆☆☆☆
USD 40/hr
Contact3

Minh Tuan T.

High-achieving individual with 4+ years in medical device regulations (EUMDR & FDA) and business process development...
Create Project
★★★★★
☆☆☆☆☆
USD 85/hr
Masters of Science
United States

Regulatory and Clinical Affairs Maintained strong customer relations, providing exceptional on-site technical, clinical, and sales support to o...

★★★★★
☆☆☆☆☆
USD 85/hr
Contact3

Biomedical E.

MEDICAL DEVICE REGULATORY CONSULTANT EU-MDR | EU IVDR | SaMD | FDA | MHRA | SFDA | Germany | 7+ years’ Experience
Create Project
★★★★★
☆☆☆☆☆
USD 30/hr
MS Biomedical Engineering
Pakistan

I am Umair Ahmed, a seasoned Biomedical Engineer and Scientist offering over 7 years of comprehensive experience in the freelance medical devic...

★★★★★
☆☆☆☆☆
USD 30/hr
Contact3

Dr. Dilip B.

Endorsed by the Royal Academy of Engineering as having exceptional Talent in Biomedical and Medical sciences
Create Project
★★★★★
☆☆☆☆☆
USD 150/hr
PhD, Neuroscience
United Kingdom

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 ...

★★★★★
☆☆☆☆☆
USD 150/hr
Contact3

Dr. Diksha V.

Researcher & Writer with 11+ years of experience in biotechnology, biomedical, bioinformatics and product developmen...
Create Project
★★★★★
☆☆☆☆☆
USD 100/hr
PhD
India

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...

★★★★★
☆☆☆☆☆
USD 100/hr
Contact3

David P.

Medical Device Commercialization and Manufacturing Automation Consultant in a Regulated Environment
Create Project
★★★★★
☆☆☆☆☆
USD 170/hr
Mechanical Engineering
United States

I am a process and product development commercialization consultant and project manager with an automation and mechanical engineering backgroun...

★★★★★
☆☆☆☆☆
USD 170/hr
Contact3

Madhu S.

Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submissions & lead auditor ISO13485...
Create Project
★★★★★
☆☆☆☆☆
USD 40/hr
Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)
India

Over 10 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, ...

★★★★★
☆☆☆☆☆
USD 40/hr
Contact3

César Daniel B.

BSc in Chemistry | MScs Petroleum Engineering | PGCert in Research Methodology | SME in Molecular Characterization
Create Project
★★★★★
☆☆☆☆☆
USD 70/hr
Heavy Crude Oil Extraction - Petroleum Engineering
Venezuela

- Specialist in hydrocarbon gas chromatography using Gas Chromatographs with Flame Ionization Detection (GC-FID) and with Selective Detection b...

★★★★★
☆☆☆☆☆
USD 70/hr
Contact3

Stephane G.

Technical innovator - Medical Device Executive - Product development expert
Create Project
★★★★★
☆☆☆☆☆
USD 160/hr
Ph.D. student
United States

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-ca...

★★★★★
☆☆☆☆☆
USD 160/hr
Contact3

Dr. Pavan M.

Doctorate in Life Sciencs & Indian Patent Agent
Create Project
★★★★★
☆☆☆☆☆
USD 20/hr
PhD
India

I have a doctorate in Biological Sciences with expertise in lifestyle-associated metabolic complications such as obesity, diabetes, and liver ...

★★★★★
☆☆☆☆☆
USD 20/hr
Contact3

Dr. Arinzechukwu U.

Freelance Scientific Writer and Consultant with over 6+ years in cancer research
Create Project
★★★★★
☆☆☆☆☆
USD 100/hr
Molecular Haematology
United Kingdom

I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...

★★★★★
☆☆☆☆☆
USD 100/hr
Contact3

Dr. Murtaza Najabat A.

Medical Device Development | Healthcare Technology Specialist | Regulatory Affairs Specialist
Create Project
★★★★★
☆☆☆☆☆
USD 80/hr
PhD in Materials Science
Pakistan

I am a biomedical engineer with over 20 years of experience in medical device development and healthcare technology. Apart from academia, I hav...

★★★★★
☆☆☆☆☆
USD 80/hr
Contact3

Dr. Sathesh Kumar A.

Regulatory Affairs Specialist
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
Ph.D
India

Fourteen years of R&D, Regulatory and Medical writing experience in various disciplines across In-vitro diagnostics, medical device regulat...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Dr. Sandeep P.

Ph.D. in Chemistry with 14 years of experience in regulatory affairs of pharmaceutical products and medical devices
Create Project
★★★★★
☆☆☆☆☆
USD 30/hr
PhD (Chemistry)
India

Ph.D. in Chemistry having a total of 14+ years of experience in the pharmaceutical industry, expertise in the regulatory intelligence of pharma...

★★★★★
☆☆☆☆☆
USD 30/hr
Contact3

Dr. Trinadh Venkata Satish T.

Experienced research scientist keenly interested in contributing to medical devices, health care and biotech projects.
Create Project
★★★★★
☆☆☆☆☆
USD 50/hr
Postdoctoral Research (Department of Molecular Cellular and Developmental Biology)
Netherlands

Experienced Research Scientist with a Ph.D. and over 20+ years of demonstrated history of working in the areas of Tissue Engineering, Infectiou...

★★★★★
☆☆☆☆☆
USD 50/hr
Contact3

Dr. Imen F.

Freelance: Quality Assurance/ Regulatory Affairs specialist in Medical Devices (MD)
Create Project
★★★★★
☆☆☆☆☆
USD 150/hr
Quality Expert
France

PHD pharmacist, with more than 5 years of experience in Quality Assurance (QA) and Regulatory Affairs (RA). My experience enables me to help yo...

★★★★★
☆☆☆☆☆
USD 150/hr
Contact3

Kolabtree is the leading online marketplace for ISO 13485 consultants. Post your project, get bids, and hire an ISO 13485 expert.

pay-per-click
Confidentiality Assured

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.

Why Kolabtree

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.

Recent Projects
  • Freelance ISO consultant required
    $550.00
  • Looking for ISO 13485 consulting services
    $400.00
How it works View full page
1

Post your Project (Free)

Your project details are safe, secure and visible only to logged-in users.

2

Get Quotes & Choose Experts

Discuss your requirements in detail with the experts before accepting the final statement of work from Kolabtree.

3

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.

4

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.