35 Yrs of industry experience currently utilized as Acting VP/Director of QA/RA/ Development/Engineering/HR/Compliance Auditor/483 Remediation Project Manager as needed; Also have Document control, auditing and engineering resources as needed.
Regulatory consultation on U.S. 510(k) preparation and clinical trials set up
General training on requirements for U.S. PMA (Pre-Market Approval) application
Regulatory consultation on the CE Marking process, Authorized European Representative agreements, Technical Dossier creation, training on regulatory requirements
Regulatory planning - Services relate to plan creation and or assessment of a company's regulatory plan as a part of due diligence activities for acquisition or investment reviews
Comprehensive Due Diligence Audits for acquisition assessments
Audits and QMS set up for ISO 9001:2008; ISO 9001:2015
Audits and QMS set up for ISO 13485:2003, ISO13485:2016
Assess compliance to 21 CFR Part 820, 801, 803, 606 and 11
Intro training and audits per the Medical Device Directives
Internal Auditing - training, audit as an ongoing contract internal auditor (annually) or one-time audit
Clinical Trials and CRO [CLIA Laboratory] Audits How to plan for a Notified Body audit - gap assessments and Do's and Don'ts
How to plan for an inspection by the FDA - Do's and Don'ts and gap assessments
Operations and Engineering
Facilities Start Up and/or Transfer - Facilities Qualification
Process/Software Validation Master Planning/Execution (FAT, SAT, IQ, OQ, PQ)
The pragmatic use of Six Sigma Tools and Techniques; Kiazen and 5S training and deployment (managing the workplace[gemba], waste elimination [muda], standardization)
Design for manufacturability and design transfers
Quality engineering for design, manufacturing, molding, extrusion and automation (including Cost of Quality, FMEA, DOE, Cpk studies, SPC implementation, value stream mapping, process flows, gage R&R;, MSE, 5M, 8D and more)
Project Management - training and or assessment
Business Continuity Planning, audits and testing of the process
Resource and skill set assessments for organizational realignment and operational excellence
Think Global - A program designed to enlighten participants on valuable tips, things to think about and implement before working outside of the U.S.
Contact us today for a quote that can be customized to your specific compliance partnership need.
Our projects are your projects - let us know what you need help with and we will partner with you for success
The Echelon Leadership Academy
ASK ABOUT GROUP AND INDIVIDUAL LEADERSHIP TRAINING FOR YOUR YOUTH/YOUNG ADULT
Jr Echelon Ages 8-12
Sr Echelon Ages 13-17
Echelon Elite Ages 18-22
With Educational and Fun Initiatives
Officer Elections to run their Camp Business and learn how to be a young Entrepreneur
Engage with Fortune 500 Companies
The UpLift Center
1555 S Gilbert Rd Suite 107
Mesa AZ 85204
College Freshman Divisions
The Top 3 Benefits of joining the Echelon Leadership Academy:
1. Catapulting Experience
Your student will gain that edge that will make him or her a better candidate for the jobs they seek in the corporate world
Your student will be exposed to various careers and skillsets crucial to success in domestic and global positions
Your student will have a greater understanding of how teamwork propels them into a successful career as a leader and sets them apart in the workforce
HOW TO REGISTER???
Registration is done by applying via an interest email to the email address below, attending an interview (dressed business casual), supplying transcripts of past 2 semesters and a 100 word minimum letter (typed or hand written) as to why you feel you should attend this program.
For more information, scholarship details and registration forms contact
or email her at
"Krystylle has done a wonderful job directing QARA at GMSbiotech and also as de facto head of Development as we await hiring a VP of Development. She has a deep knowledge of FDA related matters and the overall development process."
Mike Hogan CSO at GMS Biotech
"Krystylle is a true expert in the Quality & Regulatory field. She has provided the leadership to support the implementation and ongoing improvement of our quality systems, leading to successful ISO 9001 & 13485 certification. She is an excellent communicator with all levels of the organization, with customers, and with external auditors. I strongly recommend consideration of Krystylle and her company G3 Quality and Regulatory Auditing and Consulting."
Alastair Malcolm CEO, Applied Microarrays Inc
“I worked with Krystylle for four years at Motorola Biochip Systems/Life Sciences as Director of Chemistry and R&D.; R&D; in general is notoriously difficult to convert to the idea of a quality system. Krystylle, through a combination of well-thought out application of QA to R&D; needs, considerable skill, and the force of her delightful personality, convinced the skeptics. She is an excellent leader for QA, because she not only implements the system, but makes it work by getting people to buy into the idea. She is also an excellent auditor, attuned to details, but not focused on trivialities. She sees the overall picture and the role quality must play in it. I would hire Krystylle as an auditor, consultant, or a full time quality director without any hesitation. I recommend her most highly.”
Chuck Brush Dir R&D; , Motorola Life Sciences
Krystylle Richardson, President of G3 Quality & Regulatory Auditing & Consulting Group, has been invaluable as a MedApps' consultant. Krystylle completed an internal ISO 13485/MDD audit of our Quality Management System, performed two supplier audits, and provided guidance on quality/regulatory questions. With her support and experience, MedApps received ISO 13485, ISO 9001, & MDD certifications during our first registration audit. MedApps would not have been able to have the QMS success without her assistance.”
Bobbi Sanchez (client) Top qualities: Great Results, Expert, High Integrity
“I had the pleasure of working with Krystylle at Amersham/GE healthcare Codelink operations. As Director of Quality, Krystylle's enthusiasm, teamwork, talent and professionalism created an outstanding quality culture within the Codelink organization. I would highly recommend Krystylle for your quality systems needs.”
Peter Kahn Director Systems Engineering, GE Healthcare
HOW TO BOOK KRYSTYLLE OR HER TEAM???
For more information, contact
or email her at
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