Medical Devices & IVD in 100+ countries

Pattern of USA Inc. is consistently engaged in projects encompassing:

Regulatory Affairs and Compliance

Quality Assurance in Regulatory Surveillance

Uninterrupted Supply Chain Security

Cost Efficiency in Regulatory Projects

Innovation and Research Compliance

Global Market Access and Business Development

Current Patient Safety Requirements

Adaptability to Emerging Technologies

Sustainability and Adherence to Post-Marketing Prerequisites

Browse Simplified Regulatory Affairs Roadmaps below

Discover the Benefits of Choosing Pattern of USA Inc. as End-To-End Provider

As a prominent global Regulatory Affairs Solutions and Services Provider, Pattern of USA Inc. offers invaluable assistance to a wide range of Life Sciences companies, from startups to small, mid-sized, and large corporations, as well as major players in the global medical device industry. Our team comprises regulatory professionals, including former officers from National Regulatory Authorities (NRAs/NCA), possessing extensive knowledge of current requirements and compliance standards.

In the dynamic landscape of global health authorities, Regulatory Affairs services play a pivotal role in ensuring the successful development and commercialization of products. Compliance throughout this intricate and ever-evolving process is a mandatory prerequisite. To navigate the complexities across the product life cycle, organizations turn to proven experts for Regulatory Affairs consulting. Our expert team acts as a vital link between organizations and National Regulatory Authorities, diligently tracking all key regulations related to the product and the prerequisites for its launch.

As a specialized global Regulatory Affairs Consulting partner, Pattern of USA Inc. serves as a bridge between organizations and key NRAs/NCAs, including, but not limited to:

– U.S. FDA (Food and Drug Administration) – United States

– EMA (European Medicines Agency) – European Union

– MHRA (Medicines and Healthcare products Regulatory Agency) – United Kingdom

– PMDA (Pharmaceuticals and Medical Devices Agency) – Japan

– Health Canada – Canada

– TGA (Therapeutic Goods Administration) – Australia

– ANVISA (National Health Surveillance Agency) – Brazil

– CFDA (China Food and Drug Administration) – China

– KFDA (Korea Food and Drug Administration) – South Korea

– SFDA (Saudi Food and Drug Authority) – Saudi Arabia

Pattern of USA Inc. stands out as a leading Regulatory Affairs services company, pioneering the provision of strategic multidisciplinary Regulatory Affairs consulting services globally. Our comprehensive Regulatory Affairs services cover the entire spectrum of product development, registration, and commercialization.

Pattern of USA Inc. global Regulatory Affairs services consultants empower Med. Device and IVD companies to comprehend and effectively manage the intricate complexity of diverse Regulatory requirements. This enables them to successfully launch their products in new markets and maximize market value. Our expertise spans Regulatory Strategy, Regulatory Intelligence, On-time Submissions for Market Authorization, Post-Approval Product Maintenance, and other related functions.

Prep Activities

Regulatory Intelligence: Continuous monitoring and analysis of regulatory changes for informed decision-making.
Intellectual Property Rights Protection: Vigilant safeguarding of intellectual property to preserve innovations.
Regulatory Compliance and Gap Analysis: Thorough assessment and rectification of compliance gaps to ensure regulatory adherence.
Q-Sub Activities: Strategic preparation and submission of pre-submission questions to the FDA for clear regulatory guidance.
Authorized Representative (EU AR & US Agent): Comprehensive support as an authorized representative, facilitating regulatory processes in both the EU and US.
De Novo NRA Classification: Expert classification services for the De Novo pathway for novel medical devices.
Breakthrough Devices Program: Assistance with applications and compliance for the FDA’s Breakthrough Devices Program to expedite market entry.
IDE Submission and Clinical Trial Support: Guidance and support for Investigational Device Exemption (IDE) submissions and clinical trial management as a US sponsor.
Pre-Audit Assessments:
- GMP, GCP, GLP, GDP, GVP: Rigorous evaluations to ensure compliance with relevant regulations across different domains.
CRO Monitoring: Proactive oversight and monitoring of Contract Research Organizations to maintain quality standards throughout clinical trials.

Submission Activities

New Market Authorization:
- US and EU Class I, II(a,b), III: Expert assistance for new market authorizations across different classes.
- Class I-IV (Other countries): Support for market authorizations in various international markets.
Premarket Notifications:
- 510(k): Guidance and support for Premarket Notifications to the FDA for Class I and II devices.
Premarket Approval (PMA): Comprehensive assistance with Premarket Approval submissions for Class III devices.
Product Name Change (EU): Assistance with changing the invented name of a medicinal product in the EU.
Device Safety/Effectiveness Change: Support for submissions related to changes in device safety and effectiveness.
Labeling and Package Leaflet Change: Assistance with changing labeling and package leaflets in compliance with regulatory requirements in both the EU and USA.
Technology, Engineering, and Performance Changes: Guidance for submissions related to changes in technology, engineering, and performance of devices in the USA.
MA Renewal: Support for the renewal of Marketing Authorizations to maintain compliance.
Medical Device Recall: Assistance with managing medical device recalls in compliance with regulatory requirements.
Corrections and Removals: Support for corrections and removal activities as required by the FDA.
FDA Establishment Services:
- Registration: Assistance with FDA Establishment registration.
- Recognition: Support for FDA Establishment recognition.
- Inspection: Guidance and support for FDA Establishment inspections.
GMP Compliance:
- Recognition: Verification for Good Manufacturing Practice (GMP) certification.
- Inspection: Support for GMP inspections and certification.

Post-Market Activities

Medical Device Vigilance: Continuous monitoring and reporting of adverse events to ensure product safety and compliance.
Post-Authorization Efficacy Study (PAES): Assistance in conducting and managing post-authorization efficacy studies to evaluate product effectiveness.
PMSR Preparation and Submission:
- Class I: Expert preparation and submission of Post-Market Surveillance Reports for Class I devices.
PSUR Preparation and Submission:
- Class II and III: Thorough preparation and submission of Periodic Safety Update Reports for Class II and III devices.
Annual Compliance Update: Provision of annual updates to ensure ongoing compliance with regulatory standards and requirements.

Selected Add-Ons

Commercial Ad, Labeling, and Health Claims Compliance Check: Thorough review and validation of commercial advertisements, labeling, and health claims for regulatory compliance.
Randomized Labeling for CRO: Customized labeling solutions for Contract Research Organizations (CROs) to meet specific study requirements.
Single-Lay User Prototype UI/UX Testing: User interface and user experience testing for single-lay users to ensure product usability and compliance.
MA Transfer: Smooth transition of Marketing Authorization from one entity to another, ensuring regulatory compliance throughout the transfer process.
Sunset Clause and MA Closing Activity: Management of Sunset Clause obligations and activities related to Marketing Authorization (MA) closure.
Product Launch Support: Comprehensive assistance to ensure a smooth and successful launch of medical devices and IVDs into the market.

See selected Simplified Regulatory Affairs Roadmap samples below. Send us an RFI/RFP for specific details in the relevant country.

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