Candace F. Cederman, MS
Principal Consultant
Candace Cederman is a Principal Consultant at CardioMed Device Consultants with more than 30 years of experience in medical device regulatory affairs,…
Read bio →Quality Systems & Manufacturing
Quality systems that support approval, inspection readiness and long-term compliance.
CMDC helps you design, implement and improve quality systems and manufacturing processes that meet FDA and international expectations. Whether you’re building a quality system from the start or preparing for an inspection, our experts help you find gaps early and fix them before they become findings.
How we can help
STARTING OUT
Build your quality system
We design a quality system sized for where you are today, with processes that can grow with you into commercial manufacturing.
GROWINGv
Strengthen what you have
We assess your existing quality system against current requirements, then plan and support the remediation.
INSPECTION AHEAD
Get inspection-ready
We run mock FDA inspections and internal audits, so your team knows what to expect and your gaps are closed in advance.
Why CMDC
A quality system built with the regulator in mind.
FDA insight in every decision
Our experts know what FDA investigators look for, and design and review your processes with that in mind.
Inspection readiness built in
Mock audits, gap assessments and CAPA support help you find and fix issues before an investigator does.
Quality connected to your submissions
Our quality, regulatory and clinical experts work together, so your design, manufacturing and submission documents tell one consistent story.
Our Capabilities
What we do for you.
Quality system design and implementation
A quality system that fits your company today and scales with it.
- Quality systems aligned with FDA's QMSR and ISO 13485
- Scalable processes from development to commercialization
- Gap assessments and remediation planning
GMP and ISO 13485 compliance
Compliance with the requirements that matter for your markets.
- GMP compliance support
- ISO 13485 certification readiness
- Alignment with international regulatory expectations
Quality in your submissions
Manufacturing and quality sections that hold up to FDA review.
- Preparation and review of manufacturing and quality system sections
- Consistency across design, manufacturing and regulatory documents
- Support for IDE, 510(k), De Novo and PMA submissions
Audit and inspection readiness
Confidence going into an FDA or notified body inspection.
- Mock FDA inspections
- Internal audits and gap identification
- Corrective and preventive action (CAPA)
- Team preparation for FDA and other regulatory inspections
Manufacturing and process support
Manufacturing that is controlled, repeatable and compliant.
- Manufacturing process development
- Process control strategies
- Aligning manufacturing operations with your quality system
STANDARDS AND REGULATIONS
The requirements we work with every day.
FDA's Quality Management System Regulation (QMSR) now aligns with ISO 13485. We can help you make the transition.
- FDA QMSR (21 CFR 820)
- ISO 13485
- GMP
- CAPA
- Mock FDA inspections
- Internal audits
- Gap assessments
- Remediation
- Process control
- ISO 14971
- 483 and warning letter response
- MDSAP
MEET SOME OF THE EXPERTS
The experts behind your program.
Diana Williamson
Principal Consultant
Diana Williamson is a Principal Consultant at CardioMed Device Consultants with extensive experience in medical device development, design controls, and regulatory compliance.…
Read bio →Dwight Back, PhD
Affiliate Consultant
Dwight D. Back, Ph.D., has worked in a high-level technical capacity across the spectrum of high tech industries from medical devices to…
Read bio →Gary Binyamin, PhD
Affiliate Consultant
Dr. Binyamin works with CardioMed Device Consultants as an affiliate consultant. He has over two decades of experience successfully bringing therapeutic products…
Read bio →Jennifer Asleson, CBA, CPGP
Affiliate Consultant
Jennifer Asleson is an Affiliate Consultant with CardioMed Device Consultants, focused on sterilization, microbiology, and sterile barrier systems. She brings more than…
Read bio →Lisa Bellincampi, PhD
Affiliate Consultant
Dr. Lisa Bellincampi is an Affiliate Consultant with CardioMed Device Consultants, bringing about 20 years of experience in research and development and…
Read bio →Ready to advance your device program?
Tell us about your device and timeline.