Services
Ready, Set, Compliance!
Are you ready to redefine excellence in the medical device industry? I bring to you a proven track record and a passion for crafting robust Quality Management Systems (QMS) that not only meet but exceed ISO 13485 standards. I can support you on all regulatory submissions including FDA, EU MDR, ANVISA, JPAL, TGA, MD SAP and COFEPRIS. Let's embark on a transformative journey together!
Start your manufacturing in Mexico
If you are looking to start up or set up new manufacturing or manufacturing transfer to Mexico, we are your solution.
We specialize in medical devices, electronics, med-tech, molding, extrusion, automation and manual assemblies; this includes all permits, manufacturing, certification, staffing, purchasing, location, basic everything.
Reach out and we will get you on your way to manufacturing in Mexico.
Global Compliance
Navigating the complexities of ISO 13485 on a global scale is my forte. Whether it's Europe, the USA, LATAM, or Asia, I understand the nuances of international regulatory landscapes, ensuring your QMS is globally recognized.
Training
The medical device industry is poised for groundbreaking advancements. Now is the opportune moment to fortify your organization with a QMS that not only ensures compliance but sets the stage for a future of unparalleled success.
Training and Certification is the key to success in any business. We will prepare your team on all areas of compliance.
Please reach out for a quick quote.
About Us
Policy
Mission
Mission
Our company is committed to providing high-quality services that meet and exceed customer expectations and comply with all applicable regulatory requirements, including ISO 13485:2016. We are dedicated to continuous improvement and the prevention of nonconformities throughout our process.
Mission
Mission
Mission
Our mission is to provide expert guidance and support to medical device companies to ensure compliance with applicable regulatory requirements. We strive to enable our clients to achieve their business goals while maintaining the highest standards of quality and patient safety.
Vision
Mission
Vision
Our vision is to be the premier subject matter expert in medical device compliance, providing unparalleled expertise, guidance, and support to clients worldwide. We aim to be the go-to resource for companies seeking to navigate the complex and ever-changing landscape of medical device regulations, and to help them achieve their goals of improving patient outcomes and enhancing public health.
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Training and Certification
Risk Management
6 hours
Embark on a journey into the realm of risk management with our comprehensive training course. Designed for professionals across industries, this program equips participants with the knowledge and skills needed to navigate and mitigate risks effectively in today's dynamic business landscape.
CAPA and RCA
15
Enter a transformative learning experience designed to elevate your skills in Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA). This comprehensive course equips participants with the knowledge and methodologies essential for identifying, addressing, and preventing issues within organizational processes.
Complaint handling and response
15
Dive into a transformative learning experience that focuses on mastering the art of complaint handling and crafting effective responses. This course is tailored to equip participants with the skills needed to navigate customer concerns, enhance satisfaction, and maintain a positive reputation for your organization.
KPIs
9
Let's demystify Key Performance Indicators (KPIs) and unlock their power to drive organizational success. This course is designed to equip participants with the knowledge and skills needed to strategically implement, measure, and leverage KPIs for informed decision-making.
MSA
12
Take this Measurement System Analysis (MSA) course and elevate your proficiency in ensuring precision and accuracy in measurement processes. This course is tailored to equip participants with the knowledge and skills needed to assess and enhance the reliability of measurement systems.
Calibration
8
Commence with a learning experience to unravel the intricacies of calibration and enhance your skills in maintaining precision and accuracy in measurement equipment. This course is meticulously designed to equip participants with the knowledge and techniques needed to conduct effective calibrations and ensure the reliability of measurement instruments.
Preventive Maintenance
8
Come and unlock the power of preventive maintenance and enhance your ability to proactively manage equipment, facilities, and assets. This comprehensive course is designed to equip participants with the knowledge and skills needed to implement effective preventive maintenance strategies for optimized performance and operational resilience.
Management Review
12
Understand, develop and improve the power of effective management reviews and elevate your organizational decision-making processes. This course is meticulously designed to equip participants with the knowledge and skills needed to conduct insightful and impactful management reviews, fostering continuous improvement and excellence.
Process Validation
20
Master the art of compliance-based process validation. This comprehensive course is designed for professionals in regulated industries, providing essential knowledge and skills to ensure processes meet stringent quality and regulatory standards.
Yellow Belt
30
Embark on a foundational learning journey designed to introduce you to the world of Lean Six Sigma. The Yellow Belt Training Program equips participants with essential knowledge and skills to contribute effectively to process improvement initiatives within their organizations.
Clean Room Validation
20
Take this specialized learning journey designed for professionals in industries where clean environments are critical. This Clean Room Validation Training Course provides comprehensive knowledge and practical skills to ensure the stringent validation of clean rooms, crucial for maintaining the integrity of processes and product quality.
GDP
20
This learning course is designed to empower professionals with the knowledge and skills needed to uphold the principles of Good Documentation Practice. This course ensures participants understand the critical role documentation plays in quality management and regulatory compliance across various industries.
GLP
9 hours
This is a specialized learning journey tailored for laboratory professionals. This Good Laboratory Practice Training Course is designed to provide comprehensive knowledge and practical skills in adhering to GLP standards, ensuring the reliability, integrity, and quality of laboratory data.
PFMEA
9 hours
Become proficient in Process Failure Modes and Effects Analysis (PFMEA). This training course is designed to equip participants with the knowledge and skills needed to proactively identify, assess, and mitigate potential failure modes in processes, ensuring operational excellence and continuous improvement.
Part 11
9 hours
This course is designed for professionals in regulated industries. This CFR 820 PART 11 Training Course is meticulously crafted to provide comprehensive knowledge and practical skills for compliance with the Code of Federal Regulations (CFR) Title 21, Part 11, which governs electronic records and electronic signatures in the context of the U.S. Food and Drug Administration (FDA).
Part 21
40 hours
This course is tailored for professionals in the medical device industry. The CFR 820 PART 21 Training Course is meticulously designed to provide comprehensive knowledge and practical skills for compliance with the Code of Federal Regulations (CFR) Title 21, Part 21, governing medical devices, complaint files, and mandatory reporting in the context of the U.S. Food and Drug Administration (FDA).
Internal Auditor ISO13485
40 hours
Designed for professionals seeking proficiency in internal auditing. The Internal Auditor Training Course is meticulously crafted to equip participants with the knowledge and practical skills needed to excel in the role of an internal auditor, ensuring effective quality management, compliance, and continuous improvement within organizations.
Audit Techniques
8 hours
Embark on a specialized learning journey tailored for professionals seeking proficiency in audit techniques. The Audit Techniques Training Course is meticulously designed to equip participants with the knowledge and practical skills needed to conduct effective audits, ensuring thorough examination, compliance, and continuous improvement within organizations.
Project Management
30 hours
Take this comprehensive learning journey tailored for professionals seeking proficiency in project management. This training course is meticulously crafted to equip participants with the knowledge and practical skills needed to excel in planning, executing, and closing projects successfully. Participants will gain insights into industry-standard methodologies, best practices, and tools essential for effective project management.
Services
Services
Regulatory Submissions
In the complex landscape of regulated industries, ensuring compliance with stringent regulatory requirements is paramount. Introducing our specialized Regulatory Submission Services, designed to streamline the process of submitting essential documentation to regulatory authorities.
Project Management
Embarking on a new project? Navigating the complexities of project management is crucial for success. Introducing our Project Management Services, designed to elevate your project from conception to triumph.
Supply Chain & Trade Compliance
In the dynamic world of international business, trade compliance is not just a necessity; it's a strategic advantage. Unveil the full potential of your global trade operations with our specialized Trade Compliance Services.
ISO13485 Implementation
Embarking on the journey to ISO 13485 certification? Ensure a seamless and successful implementation with our specialized ISO 13485 Implementation Services.
Audit/Inspection Readiness
Navigating audits and FDA inspections demands meticulous preparation. Introducing our specialized services designed to fortify your organization's readiness for regulatory scrutiny.
Quality Management System Implementation
Embarking on the journey to implement a robust Quality Management System? Ensure success with our specialized QMS Implementation Services.
Assessments
In the ever-evolving landscape of regulations, ensuring compliance is not just a necessity; it's a strategic advantage. Discover peace of mind with our specialized Compliance Assessments Services.
NPI & Product Transfers
2
Embarking on a production transfer? Make the transition smooth, efficient, and successful with our specialized Production Transfer Services.
Shelter
Navigating fluctuations in staffing needs or launching a short-term project? Embrace agility with our specialized Temporary Staffing Services.
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