About OneRA

OneRA delivers rapid, positive responses from the FDA and global regulatory authorities whether it be related to a submission, audit and inspection observations, quality systems or the day-to-day activities of most medical device companies. Whatever your needs or concerns are, we can help. We have over +30 years of medical industry experiences in regulatory, quality, engineering, and manufacturing. We have worked with medical device startups and leading global providers of world-class devices and treatments.

Regulatory Affairs is an ever-learning adventure. We research regulations globally and understand the technology behind the devices we work with. We uphold trust-based internal relationships with Regulatory Affairs, gathering all information before communicating a submission strategy. This applies to every aspect of the medical device industry we support.

Results Through Partnership

We get great results by partnering with the regulatory bodies early in the process, while keeping the team goal-focused. We have a knack for finding viable paths to rapid approval and resolution.

Servant
Leadership

We create work environments that foster growth, recognition, and opportunity. Truly believing and communicating that people are the company’s greatest asset inspires them to engage and deliver.

Cost-Effective Systems

We have implemented data management systems that cut administrative time and expenses.

Regulatory Expertise

  • Achieved PMA submission within 3 months, ending >1 year of attempts to complete project. Galvanized team with clear communication, resolving chronic misunderstandings and conflicting data reports.
  • Enabled continued commercialization in EU, achieving ISO 13485:2016 certification and Medical Device Single Audit Program (MDSAP) transition audit within 4 months. Conducted gap assessment and trained quality manager.
  • Led successful FDA Pre-Approval Inspection (PAI), achieving Voluntary Action Indicated (VAI) designation. PAI was originally expected earlier but stalled. Implemented all regulatory strategies and corrected resulting 5 minor observations, completing 15-day comprehensive response.
  • Supported early revenue increases, reducing company internal timeframes for FDA product approvals and clearances, including: 180-day Supplement review time reduced from 6 months to 3–5 months; Real-time PMA Supplement from 180 days to 90 days; Traditional 510(k) from 180 days to 90–120 days; Special 510(k) from 90 days to 30–45 days.
  • Within 4 months, incorporated vital component of U.S. commercialization success, clearing use of a new indication for pediatric patients and ending 2 years of failed attempts. Organized and submitted materials, gaining 510(k) clearance and increasing sales.
  • Paved way for U.S. sales, representing $M’s in revenue. Completed final response to FDA within 15 days and achieved PMA approval, leading and managing response to FDA and follow-up inspection.

Strategic and Tactical

  • Gained FDA PMA approval for AAA stent within 1 year of addressing 3 FDA not approvable letters. Improved team’s relationship with FDA, helping members understand collaborative processes and replacing resistance with optimistic cooperation. Worked with Engineering to retest and address issues with stent that had stymied approval.
  • Enabled generation of $1M+ / month by positioning Regulatory to speed new-product approvals, allowing early commercialization of products. Quickly recruited and trained 5 directors to positions that had been vacant for months.
  • Minimized inventory stockpiling, implementing global transition of inventories. Kept company-wide manufacturing transition activities aligned to finish within 30-day window by contracting or hiring highly skilled, local regulatory professionals who tightly coordinated activities.
  • Quickly resolved stalled FDA extension response, collaborating with FDA to develop approval path and barrier to entry for competitors. Presented 510(k) novel device as accessory to high-risk device, precluding device’s potential use as predicate for other companies. Strategy both resolved team’s distrust of FDA and increased FDA’s goodwill toward the company.
  • Increased revenue, allowing global exports by transitioning manufacturing to U.S. Sustained FDA registrations and passed FDA inspections.
  • Within unprecedented 6 months, mitigated risk of consent decree and secured continued commercialization in EU, representing 100% of future EU revenue and 70% of future total revenues. Developed and implemented Quality System Action Plan (QSAP), ensuring compliance with both FDA quality system regulations and ISO 13485. Achieved replacement ISO 13485:2003 certification, presenting all needed evidence.

Solutions that Fit Needs

  • Raised employee satisfaction survey results from 50’s to 90’s. Introduced “Career Ticket” program to define growth paths in collaboration with HR and convince employees of company’s appreciation of their value. Optimized employee talent, placing individuals in best-suited roles.
  • Transitioned all registration transfers within two years of initiation, creating and implementing global strategic plan throughout 70+ countries where commercialization was active.
  • Six months earlier than anticipated, completed certification audits for multi-divisional global medical device company. Automated imports and handling of thousands of documents and records, installing ISO 13485:2003-compatible global quality management system.
  • Prepared company for spontaneous FDA audits and inspections, implementing an electronic quality management system to provide real-time status updates and ensure compliance of all processes.

Collaborative Solutions

  • Reversed company’s inability to attract talent, recruiting and training 11 talented employees. New hires expanded team from 11 FTEs and 11 consultants to 22 FTEs.
  • Reduced employee attrition rate from 15% annually to 0% annually, developing and implementing rewarding career maps and succession planning strategies.
  • Halted costs of noncompliance, previously in $M’s. Reorganized Regulatory and Quality departments, promoting qualified candidates and recruiting personnel to maintain certifications and resolve noncompliance issues, allowing new revenue streams from associated products.

Cost-Effective Solutions

  • Increased revenues from Class III product 60% by positioning novel 50(k) device as an accessory. Solution resolved surgeons’ safety concerns around device malfunction, allowing additional use Class III device.
  • Improved tracking efficiency 40% and saved $100K’s annually by identifying and implementing a global electronic regulatory information management system (RIMS) to track hundreds of product registrations. System managed submissions and approvals for products in 70 countries and enabled scalable growth, preventing need to hire 4 staff for administrative work alone.
  • Reduced costs, converting many contract personnel to full time by providing rewarding career paths and growth opportunities.

Technology Expertise

  • Increased process efficiency 50%, reduced department headcount, and improved compliance, sponsoring and implementing a global electronic quality and regulatory data management system within 3 months.
  • Enabled Sales and Marketing to meet forecasts, implementing global regulatory information management system to track hundreds of global registrations. System showed sales reps alternative available markets.
  • Allowed growth without additional headcount for subsequent 3 years, implementing scalable electronic quality management system.

Engineering Expertise

  • Reduced time to submit registration approval applications from 3–4 months to within days of receiving last project deliverable. Provided key regulatory resources. Ended company-wide inconsistency of regulatory support to franchises by developing and leading regulatory sub-teams that supported >60 franchise projects.
  • Rebuilt internal respect and appreciation of Regulatory Affairs, realigning talent with appropriate skills and goals, providing development paths, and creating new opportunities. Subsequently, recruiters and job seekers contacted company as a desirable workplace and companywide trust of department generated positive collaboration.
  • Saved CE Mark approval in EU, working with R&D to update 5 design dossiers, including 3 that were flagged noncompliant and threatened loss of CE Mark approval for all products in EU.