Medical Device Services• DHF & Technical File Remediation • Date Integrity Services ••...
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Medical Device Services
Transcript of Medical Device Services• DHF & Technical File Remediation • Date Integrity Services ••...
Medical Device Services
PHONE: 262.288.6300 | FAX: 262.857.2278 | WEB: www.rcainc.com
Regulatory Compliance Associates® Inc.’s (RCA) breadth of expertise in the Medical Device Industry is globally renowned and in demand. Our broad range of regulatory services include regulatory support such as regulatory staff augmentation; global regulatory strategy and submissions; regulatory due diligence, assessments, and audits; and strategic consulting on new products development, lifecycles, and staffing support.
RCA enlists over 500 top industry experts, blending FDA veterans and seasoned regulatory affairs leaders. Who we help:
• Start-ups and Virtual Life Science Companies that want to leverage the benefits of outsourced services
• Large, medium and small, family-owned enterprises
• Companies new to FDA and medical device regulations
• Domestic and International companies expanding to new geographic markets or seeking local assistance
• Law firms seeking experts in remediation of 483’s, Warning Letters, Consent Decrees or Import bans
Regulatory AffairsRegulatory Affairs is our backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide, therefore you can count on us for in-depth and up-to-date insights which increase speed-to-markets.
• New Product Approval Support
◦ Global Regulatory Strategy
◦ Pre-Submissions Support
□ Preparing and Conducting Pre-Submission Meeting
□ Regulatory Strategy
□ Evaluation of ISO 13485 & FDA Compliance
◦ Domestic & International Submissions
◦ Post-Submission Services
□ FDA Establishment Registration & Device Listing
□ U.S. Agent Services
• Post Approval Support
◦ Root Cause Investigation
◦ Labeling Review & Assessment
◦ Post Market Surveillance
◦ Medical Device Reporting / Adverse Event Reporting
◦ Recall Management
◦ Compliant Handling
◦ Re-submission Assessment & Remediation
Areas of Expertise
Anesthesiology | Cardiovascular | Combination Devices | Dental | Ear, Nose and Throat
Gastroenterology/Urology | General Hospital | Hospital Hardware | In Vitro Diagnostics
Obsterics/Gynecology | Ophthalmic | Radiology | Surgical Devices | Wound Care
Compliance
Standards
Regulations
• Additional Services
◦ Outsourced Regulatory Affairs
◦ Regulatory Affairs Training
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Top Medical Device Observations October 1, 2016 - September 30, 2017
21 CFR 820.100(a) Lack of or inadequate procedures
21 CFR 820.198(a) Lack of or inadequate complaint procedures
21 CFR 820.50 Purchasing controls, Lack of or inadequate procedures
21 CFR 820.75(a) Lack of or inadequate process validation
21 CFR 803.17 Lack of Written MDR Procedures
21 CFR 820.90(a) Nonconforming product, Lack of or inadequate procedures
Compliance AssuranceIncreasingly, Life Science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, RCA can help.
• Assessments
◦ 21 CFR Part 11 / Annex 11 Assessment
◦ 21 CFR Part 820 Assessment
◦ ISO 13485 Assessment
◦ ISO 9001 Assessment
◦ Mock Inspection / Gap Assessment
• Audits
◦ Internal, Contract Manufacturing & Supplier Audits
Quality Assurance
RCA’s consultants are Quality experts with experience spanning start-ups and major corporations. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
• Outsourced Quality Support
• Quality System Implementation
• Risk Management (ISO 14971)
• ISO 13485
• 21 CFR Part 820
• Laboratory Support
◦ Standard Operating Procedure (SOP) Development
◦ Method Transfer
◦ Method Validation
Compliance
Standards
Regulations
• Regulatory Agency Action Response
◦ 483 Response
◦ Warning Letter
◦ Consent Decree
◦ Import Bans
• Notified Bodies
◦ Responses
400
269138
137
127
127
Top Medical Device Observations October 1, 2016 - September 30, 2017
21 CFR 820.100(a) Lack of or inadequate procedures
21 CFR 820.198(a) Lack of or inadequate complaint procedures
21 CFR 820.50 Purchasing controls, Lack of or inadequate procedures
21 CFR 820.75(a) Lack of or inadequate process validation
21 CFR 803.17 Lack of Written MDR Procedures
21 CFR 820.90(a) Nonconforming product, Lack of or inadequate procedures
Remediation & Strategy SupportRCA is widely recognized within the Life Science industries and global regulatory agencies for it’s ability to help companies successfully resolve complex regulatory challenges.
Our value goes beyond the initial response by helping companies successfully execute their action plans. We negotiate difficult demands or remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with us a competitive differentiator in the remediation space.
• Quality System Remediation
• DHF & Technical File Remediation
• Date Integrity Services
• Regulatory Action Remediation
◦ 483 Remedation
◦ Warning Letter Remediation
◦ Consent Decree Remediation
• Manufacturing Process, Equipment, Facility & Utility Validation
• Part 11 and Computerized System Validation
Strategic ConsultingWhether it’s a strategy, a technical plan, or project, RCA’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.
• Manufacturing Optimization & Aging Facilities
• New Product Development
◦ Project Management
◦ Design Inputs / Outputs
◦ Risk Management
◦ Design Transfer
◦ Outsourced Quality & Regulatory Support
◦ Independent Product Verification & Validation
• Product Life Cycle Management
◦ Change Management
◦ Post Product Release Risk Management
◦ Regulatory Post Product Release Support
◦ End of Life Strategy and Implementation
◦ Independent Product Verification & Validation
• Staffing Support
◦ Project Management
◦ Staff Augmentation
◦ Consulting Support
◦ Project Based Solutions Implementation
• Mergers & Acquisition / Due Diligence
◦ Regulatory Due Diligence
◦ Quality Due Diligence
◦ Facility / Equipment Assessment
◦ Personnel Assessment
◦ Post-Merger Integration
• Regulatory Agency Action Response
◦ 483 Response
◦ Warning Letter
◦ Consent Decree
◦ Import Bans
• Notified Bodies
◦ Responses
Regulatory Compliance Associates Inc. is Your Go-To Source When the FDA Calls
400
269138
137
127
127
Top Medical Device Observations October 1, 2016 - September 30, 2017
21 CFR 820.100(a) Lack of or inadequate procedures
21 CFR 820.198(a) Lack of or inadequate complaint procedures
21 CFR 820.50 Purchasing controls, Lack of or inadequate procedures
21 CFR 820.75(a) Lack of or inadequate process validation
21 CFR 803.17 Lack of Written MDR Procedures
21 CFR 820.90(a) Nonconforming product, Lack of or inadequate procedures
ISO 9001 CERTIFIED
Why Choose RCA?• We are widely recognized within the life science
industry and by global regulatory agencies for our ability to help companies successfully deal with complex regulatory challenges.
• By mining regulatory intelligence, we continuously evaluate FDA’s and other regulatory agencies current thinking and leverages thought leadership networks to advocate for our clients.
• We know a quality or compliance crisis can significantly impact your business. We have the experience to manage them.
• We have the know-how and proven approach to navigate Warning Letters, Consent Decrees and other situations.
• We know how to partner with your executive, legal and communication teams.
• We support management to assist with the growing and changing concerns.
• We help navigate the storm and manage the impact to your business.
Quick Facts About RCA:• Founded in 2000
• Headquartered in Southeastern Wisconsin with offices in West Central Florida, Northern Colorado & Central Eastern Europe
• Expertise backed by over 500 industry and FDA subject matter experts
• Regulatory Submissions in 196 different countries / dependencies
• Engagements on four continents
• ISO 9001 Certified
What our Clients are saying:
“You won’t find a more talented team, a more personable group, or one more dedicated to your success than Regulatory Compliance Associates.”
- Senior Manager of Corporate Reliability Engineering
“We would absolutely recommend RCA to set up and manage a quality system. We couldn’t afford to hire personnel with RCA’s expertise and our engagement allows us to tap into
them as needed while we focus on growing the company.”
- Vice President Operations
“RCA not only remediated our warning letter, but they also helped us prepare our teams for an upcoming audit. We received no observations during the next FDA inspection.”
- Vice President of Quality
“RCA developed the product quicker, and more importantly better, than we could have.”
- Vice President Clinical Therapies
RCA HEADQUARTERS
10411 Corporate Drive, Suite 102
Pleasant Prairie, WI 53158
SOUTHEAST REGIONAL OFFICE
720 Brooker Creek Blvd., Suite 201
Oldsmar, FL 34677
WESTERN REGIONAL COAST OFFICE
1200 Pearl Street Suite 206
Boulder, CO 80302
EUROPEAN OFFICE
ul. Postepu 15c 02-676 Warszawa, Polska
“RCA’s expertise helped complete the submission, leading to the CE Markings and enabling continuity
of existing products and expanded distribution of new product. Based on this successful experience,
we will gladly look to RCA for future needs in clinical evaluations.”
—Senior Vice President of Quality & Regulatory Affairs
ISO 9001 CERTIFIED
© 2017 Regulatory Compliance Associates® Inc. All Rights Reserved.
REGULATORY SUBMISSIONS IN 196 COUNTRIES /DEPENDENCIES | ENGAGEMENTS ON 4 CONTINENTS | OFFICES AT 4 LOCATIONS
PHONE: 262.288.6300 | FAX: 262.857.2278 | WEB: www.rcainc.com
