Hire an ISO 13485 Consultant: Find ISO experts on Kolabtree

Dr. Muhammad M.

Being Molecular biologist, my profession, not only profession but my passion is to technically write scientific stuff.
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USD 30/hr
PhD
Pakistan

"Hello and welcome to my freelance profile! I am a scientific writer and product development specialist with several years of experience ...

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USD 30/hr
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Dr. Dilip B.

Endorsed by the Royal Academy of Engineering as having exceptional Talent in Biomedical and Medical sciences
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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 ...

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USD 150/hr
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Nida A.

Experienced MDR and FDA certified CER/Technical File Writer with 7+ years of experience with multinational industries
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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...

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USD 50/hr
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Lisa R.

REGULATORY AFFAIRS - Medical Device - Biotech - Dietary Supplement - Pharma
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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...

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USD 200/hr
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César Daniel B.

BSc in Chemistry | MScs Petroleum Engineering | PGCert in Research Methodology | SME in Molecular Characterization
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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...

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USD 70/hr
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Dr. Hafsa I.

Medical Device Regulation (MDR) - BER - Technical File - CER - ISO13485 - Production manager - SOPs -
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USD 35/hr
PhD
Pakistan

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

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USD 35/hr
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Dr. Pavan M.

Doctorate in Life Sciencs & Indian Patent Agent
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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 ...

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USD 20/hr
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Dr. Murtaza Najabat A.

Medical Device Development | Healthcare Technology Specialist | Regulatory Affairs Specialist
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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...

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USD 80/hr
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Sonali S.

Experience in EUMDR, 510k submission, Risk management file, ISO 13485
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USD 20/hr
Bachelor of Pharmacy (Gold Medallist)
India

Having experience in medical device regulatory affairs, EUMDR, USFDA 510K, ISO 14971, ISO 13485

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USD 20/hr
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Beliz A.

Freelance Medical Writer, Medical Device Expert, 6+ years of Experience in Medical Device Industry
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USD 100/hr
M.S Neuroscience
Turkey

Bioengineer passionate about medical devices but even more loves to build meaningful, evidence-based relationships between medical devices and ...

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USD 100/hr
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Juan M. C.

Medical Device quality & regulatory expert with + 33 years experience in the industry
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USD 150/hr
Global Leadership
Spain

Juan M. Campos is a Medical Device professional with + 33 years of continued industry experience. His main areas of expertise include Quality A...

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USD 150/hr
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Sven A.

Bio-Research Engineer, MSc Clinical Research & Translational Medicine, RN, MSc Biostatistics
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USD 150/hr
MSc
United States

26 years experience in Research & Development of Medical Devices, Biotechnology, many years in basic science at KI, Charite, Cambridge, Oxf...

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USD 150/hr
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Biomedical E.

MEDICAL DEVICE REGULATORY CONSULTANT EU-MDR | EU IVDR | SaMD | FDA | MHRA | SFDA | Germany | 7+ years’ Experience
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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...

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USD 30/hr
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Dr. Hrishikesh G.

Over 30 years of experience commercializing medical devices for large, mid-size and early stage companies.
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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...

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USD 125/hr
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Dr. Diksha V.

Scientist & Writer | Expert in life science, cancer biology, drug discovery | Data science/analysis & bioinforma...
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USD 50/hr
PhD
India

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...

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USD 50/hr
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Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
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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...

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USD 50/hr
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Dr. Muhammad H.

Freelance Molecular biologist and Bioinformatician. I have 5+ years of experience in technical scientific writing.
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USD 50/hr
Doctor of Philosophy
Pakistan

It's me Dr.Hamdan, professionally computational biologist. My profession, not only professionally, but my passion is to interact with globa...

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USD 50/hr
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David P.

Medical Device Commercialization and Manufacturing Automation Consultant in a Regulated Environment
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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...

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USD 170/hr
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Sundeep A.

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management
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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, ...

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USD 100/hr
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Stephane G.

Technical innovator - Medical Device Executive - Product development expert
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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...

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USD 160/hr
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Rudra P.

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

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

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USD 70/hr
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Dr. Arinzechukwu U.

Freelance Scientific Writer and Consultant with over 6+ years in cancer research
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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...

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USD 100/hr
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Dr. Sathesh Kumar A.

Regulatory Affairs Specialist
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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...

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USD 50/hr
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Dr. Sandeep P.

Ph.D. in Chemistry with 14 years of experience in regulatory affairs of pharmaceutical products and medical devices
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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...

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USD 30/hr
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Dr. Imen F.

Freelance: Quality Assurance/ Regulatory Affairs specialist in Medical Devices (MD)
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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...

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USD 150/hr
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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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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.