LET US HELP BRING

YOUR MEDICAL DEVICE TO GLOBAL MARKETS

LET US HELP BRING YOUR MEDICAL DEVICE TO GLOBAL MARKETS

Personalized Regulatory Quality Compliance Branding Solutions

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Are you looking for a Regulatory Consultant?

  Schedule a meeting now

Call Us Now

+972 50 5236 435

Email Us Now

[email protected]

Why KeyMedic?

KeyMedic offers Regulatory Affairs, Quality Management System and Compliance expertise to the medical device industry, supporting entrepreneurs, startups and manufacturers throughout the product life-cycle.

  • We understand the regulations

  • We understand your needs

  • We find optimal and out of the box solutions

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Years’ Experience
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Successful Submissions
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Countries
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Successful Quality Audits

Our Services

We believe that each company and each product are unique, and with our knowledge, experience and “think outside the box” approach, we can tailor flexible solutions that will meet both your needs and capabilities, and the regulations.

Regulatory
Regulatory strategy development, preparation for pre-submissions, compilation of dossiers and submissions and license maintenance, in the EU, USA, Canada and more.
Quality
Establishment of a Quality Management System (ISO 13485 / FDA Quality System Regulations / MDSAP), preparation for inspections, on-site quality system audits and supplier audits.
Compliance

Compliance programs, post-market surveillance, risk management, customized training, audits, etc.

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We can make the process more efficient

KeyMedic supports you throughout your product life-cycle

Classification
Requirements Identification
Planning
Implementation
Compliance
Let us guide you through Medical Device regulations.

We can make the process more efficient

KeyMedic supports you throughout your product life-cycle

  • Classification

  • Requirements Identification

  • Planning

  • Implementation

  • Compliance

Special Packages for Startups

We offer customized solutions for Medical Device startups in various stages of company and product development.

BASICS PACKAGE
Regulatory
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  • Regulatory strategy consulting

  • Selection of regulatory path

  • Preparation for pre-sub meetings

  • Submission preparation and management

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Recommended
MARKET ENTRY PACKAGE
Premium
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  • Regulatory strategy consulting
  • Quality system establishment

  • Product and company branding

  • Company and brand website

  • Online shop (if needed)

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BASIC PACKAGE
Quality
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  • Quality system establishment

  • Training of individuals and teams

  • Audits for client and suppliers

  • Preparation for inspection

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OUR CREATIVE PARTNER

Taking brands

further.

Design, development and marketing company with more than 16 years of experience that delivers fantastic results on time and within a budget.
 
Parente Studio is dedicated to serving the creative needs of any company or product, is passionate about its clients' success and is willing to go the extra mile to ensure ultimate satisfaction and results.
They represent various world wide brands.
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Taking your business

to the next level

All Our Services
Startup Services

Are you looking for a Regulatory Consultant?

Call Us Now

+972 50 5236 435

Email Us Now

[email protected]

Our Offices

Tel-Aviv, Israel

Zagreb, Croatia

HAVE A QUESTION?​

Contact Us