SDRAN CONSULTANTS DIRECTORY

Accurate Consultants

We are worldwide FDA experts for the Medical Device and IVD Industries.

We are third party experts in Regulatory, Quality and Compliance Consulting that help Medical Device and IVD firms with managing their regulatory submissions from planning Pre-Submissions to submitting 510(k) premarket submissions to implementing Quality Management System Regulation (QMSR) and ISO 13485:2016 compliant Quality Management Systems. We also have experience with Class 3 medical devices and handle Premarket Approvals (PMA) and their associated reporting requirements such as supplements and annual reports.

Regulatory Affairs Solutions

Our consultants have extensive industry experience in preparing submissions and have an excellent track record for interfacing with the appropriate regulatory authorities and helping firms achieve their regulatory objectives. We specialize in the following Regulatory Services:

Medical Devices and IVD Submissions

• Pre-Submissions (Pre-subs / Q-Subs)
• Pre-Market Notifications (510(k))
• Pre-Market Approval (PMA)
• PMA Supplements (30-day / 135-day, 180-day, Real Time, Special, Panel Track) and Annual Reports

Quality System Solutions

Accurate Consultants will immediately supplement your organization to provide various quality system solutions, which will comply with ISO 13485:2016 Quality Management System Regulation (QMSR) as well as International Regulatory Authorities regulations and standards such as EU Medical Device Reporting (MDR). Accurate Consultants can engineer and supply you with the appropriate QMSR or EU/MDR compliant documentation and training. Our Quality System solutions can be customized and implemented into your organization in a seamless way for simplicity and for long term sustainability.

Compliance Solutions

Accurate Consultants offers third party audits, Mock FDA inspection audits, Regulatory Gap Analysis audits, Internal and External Supplier audits and 483 / Warning Letter Response and Remediation. We also offer Labeling Review, Risk Management, CAPA support, import/export assistance, establishment registration and device listing.

Training Services

Accurate Consultants offers a full complement of training programs for all levels of an organization from senior executives to bench technicians, to cleanroom operators to manufacturing personnel, Quality Assurance (QA) and Quality Control (QC). Training programs can be customized to meet each organization's requirements. In addition to virtual or onsite lecture format training, Accurate Consultants is also able to deliver on-the-job training and "train the trainer" services.

Website: www.accuratefdaconsulting.com
Phone: 619-517-0673
Email: [email protected]

Stephen Weber Consulting LLC

Thirty-five years experience as practicing orthopedic surgeon with four years as CDRH FDA Medical Officer and six years as independent regulatory consultant covering a wide range of device and biologic applications.

Business & Professional Services

Extensive experience with Breakthrough Applications, PMA, and De Novo as well as IDE development. Also cover EU MDR CER evaluations and medical publication as well as Independent Safety Monitor for ongoing IDEs.

Phone: +1 786-774-3636
Email: [email protected]

Kim Walker Consulting

Kim Walker Consulting provides tailored regulatory, quality systems, and clinical support for companies navigating global healthcare product requirements. We help clients optimize time to market while maintaining compliance throughout the product lifecycle.

Medical Devices • IVDs • Combination Products • OTC Pharmaceuticals • Biologics • Dietary Supplements • Cosmetics • Food Products

Regulatory Affairs

513(g) Requests, Q-Submissions (Q-Sub), Emergency Use Authorizations (EUA), 510(k) Submissions, De Novo Applications, PMA, HDE, CLIA Waivers, IDE, IND, Pre-IND, BLA, ANDA, CE Mark Technical Documentation, Health Canada Submissions, and other global regulatory submissions.

Quality Systems

GLP, GCP, cGMP, QSR, ISO 13485, ISO 14971, and Pre-Approval Inspection (PAI) audits.

Clinical Affairs

Clinical trial design, protocol development, investigator brochures, clinical management procedures, GCP audits, IND and IDE preparation, and clinical data support for regulatory submissions.

Post-Market Support

Labeling reviews, complaint handling systems, MDR and vigilance reporting, risk management, CAPA support, import/export assistance, establishment registration, device listing, FDA Form 483 responses, and warning letter review and remediation.

Training

On-site and customized training programs are available for all of the services listed above.

Website: kimwalkerconsulting.com
Email: [email protected]

Qualomics LLC

Qualomics LLC provides quality and regulatory consulting for medical device start-ups and small companies. Our mission is to add value to your organization with practical, right-sized quality systems. For organizations that don't yet have a dedicated quality or regulatory department, Qualomics helps meet FDA and ISO requirements without the overhead built for a much larger company.

Founder Erica Livingston, RAC, holds a B.S. in Biology from UC San Diego and has worked in medical device quality assurance since 2008, following a background in bench-level assay and product development at organizations including the Salk Institute, Johnson & Johnson Pharmaceutical Research, and Hologic. She holds the US Regulatory Affairs Certification (RAC) and certificates in ISO 14971 Risk Management, MDSAP, verification and validation, and Lead Auditor for ISO 13485:2016.

Qualomics works with companies developing electromechanical devices, injection-molded parts, catheters, hand tools, assay readers, diagnostics, and combination products — integrating quality, regulatory, and operations so the system supports the business rather than working against it.

Medical Devices • Diagnostics

Quality System Consulting

Strategic planning, QA operations, QMS development and implementation, off-the-shelf and custom SOPs, fractional quality management

Working With

Electromechanical Devices • Contract Manufacturers • Injection Molding • CNC / Lathe Machining • Reagents & Kits • Sterile Single-Use Devices • Consumer Goods

Auditing

Internal audits, audit preparation, FDA inspection readiness, supplier and vendor audits, audit response and remediation

Validation

Process validation, equipment IQ/OQ/PQ, software validation, validation protocols and reports

Adverse Event Reporting

Electronic eMDR reporting via ESG NextGen

Certifications

US RAC, Lead Auditor ISO 13485:2016, ISO 14971 Risk Management, MDSAP, ISO 9001 and ISO 15189

Website: qualomics.com
Phone: 858-247-6804
Email: [email protected]