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Reg Clarity Inc. |
Description: Reg Clarity Inc (RCI) serves medical device companies distributing product in the USA, Canada and Europe. Our expertise covers Class III (USA) implantable medical devices as well as lower risk and/or external non-implantable products, from initial design concept and development through formal design, clinical testing, manufacturing, regulatory submission/approval and market release/distribution.
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Reg Clarity Inc.
251 Whitmore Dr. ,
Waterloo, ON, N2K 2M5
CA
Phone: (519) 500-9733
Fax:
Email:reg-clarity@rogers.com
Website:
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Products and Services: Key service areas include strategic planning and performance on all client regulatory and quality needs throughout the product lifecycle, from design inception (R&D) through formalized development and testing, regulatory interface for clinical trails and product submissions for market release. Primary service areas also include Quality Management System (QMS) design, assistance on internal audits and mock external audits, CA/PA resolution and closure, review of product labeling, advertising and promotional materials (including website content) and press releases; field actions and recalls; product obsolescence and data archival/document control requirements. RCI does not provide services related to clinical study design, clinical statistical analysis, GCP audits or design and development standards for individual device categories; these services are provided by specialist partner organizations.
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Experience: **Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company .IDE, ITA, CE Mark, 510(k), PMA, MDL, HDE
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Featured Products and Services
![Reg Clarity Inc. - Key service areas include strategic planning and performance on all client regulatory and quality needs throughout the product lifecycle, from design inception (R&D) through formalized development and testing, regulatory interface for clinical trails and product submissions for market release. Primary service areas also include Quality Management System (QMS) design, assistance on internal audits and mock external audits, CA/PA resolution and closure, review of product labeling, advertising and promotional materials (including website content) and press releases; field actions and recalls; product obsolescence and data archival/document control requirements. RCI does not provide services related to clinical study design, clinical statistical analysis, GCP audits or design and development standards for individual device categories; these services are provided by specialist partner organizations.]()
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