Trending...
- Pittsburgh Digital Marketing Agency Moves to Babcock Boulevard in the North Hills
- New Children's Picture Book "Tippy Tay" Explores the Dangers of Peer Pressure and the Importance of
- New Children's Picture Book "Adam's Apple" Celebrates Childhood Curiosity and the Funny Misundersta
PITTSBURGH--(BUSINESS WIRE)--Rimsys, the leading provider of Regulatory Information Management (RIM) software for the medtech industry, today announced the release of the 2023 Regulatory Performance Report, a new study that tracks trends in regulatory priorities, processes, and performance within medtech companies. The report is based on a survey of 200 regulatory professionals and executives across North America and Europe.
The report explores how regulatory affairs teams are staffed, their workload, average times to complete regulatory projects, where they experience compliance issues, and the growing trend of accelerating digital transformation within the industry.
"The need for this report was driven by conversations with several of our customers," said James Gianoutsos, Founder and CEO of Rimsys. "Regulatory leaders don't have clear benchmarks to measure the performance of their teams. They're looking at digital transformation initiatives to improve the efficiency and effectiveness of their teams and want to understand what's possible, what really good execution looks like."
Key findings include:
Regulatory teams are lightly staffed compared to their workload.
A quarter of large medtech companies have 15 or fewer regulatory employees. These small teams complete over 100 renewals or license updates each year. Only 13% of companies make resourcing decisions based on anticipated workload, leaving any gaps to be filled with external consultants. Today, 90% of companies rely on consultants to complete regulatory projects.
Process failures are common.
Regulatory leaders self-assess the performance of their teams highly. A majority believe they outperform other regulatory affairs teams in similar companies in both project planning and execution. Yet over 60% reported a major non-compliance issue in that past year, and 24% had to withdraw products from a country or region due to non-compliance.
More on The PennZone
Digital transformation makes a measurable impact on productivity.
Companies are investing in process improvement, both by increasing staffing and growing technology budgets. They are moving away from generic productivity tools to more specialized solutions designed for regulatory processes. Companies that have implemented regulatory information management and regulatory intelligence systems report very high productivity gains and they complete regulatory projects more quickly.
Rimsys and PA Consulting, a global innovation and transformation consultancy, in conjunction with the Regulatory Affairs Professionals Society, will be presenting and discussing the survey findings in an interactive webinar on February 23, 2023. To attend, register here: https://bit.ly/performance-study-webinar.
"A major trend we are tracking this year is focused on Medtech's engagement with regulatory bodies against a backdrop of new requirements for advanced technologies such as AI, and evolving legislation such as the MDR and IVDR transition in Europe. This has forced organizations to re-evaluate old processes and adopt new tools," said Marck Aghnatios, MedTech Expert at PA Consulting. "The impact of this change will be largely absorbed by the regulatory affairs function – which is accurately reflected Rimsys' study findings. The industry imperative for medtech leaders will be to digitize their business functions – starting with regulatory."
Methodology
More on The PennZone
Rimsys worked with a third-party market research firm to field and administer the survey in July 2022. Survey respondents included 200 regulatory professionals at medtech (medical device, in vitro diagnostic, and software as a medical device) companies headquartered in the United States, Canada, and the European Union. Companies were evenly sampled across all sizes, from $10 million to more than $1 billion in revenue.
To download the full Regulatory Performance report, please visit: https://www.rimsys.io/regulatory-performance-report.
About Rimsys
Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software digitizes and automates regulatory activities, helping medtech regulatory affairs teams to plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys centralizes all regulatory information, automates submission processes, and provides detailed visibility into product registrations, expirations, relevant standards, and global regulations. Traditional approaches to regulatory affairs can't keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys is designed around medtech regulations and workflows and supports a full breadth of regulatory activities including registrations, submissions, UDI, essential principles, standards management, and regulatory intelligence in a single, integrated platform. Leading global medtech companies including Johnson & Johnson, Siemens Healthineers, and Omron rely on Rimsys to better manage regulatory projects and resources, get new products to market more quickly, and reduce revenue risk of non-compliance, product recalls, and unexpected expirations. For more information, visit www.rimsys.io.
Contacts
Michael Peach
(855) 846-7269
michael.peach@rimsys.io
The report explores how regulatory affairs teams are staffed, their workload, average times to complete regulatory projects, where they experience compliance issues, and the growing trend of accelerating digital transformation within the industry.
"The need for this report was driven by conversations with several of our customers," said James Gianoutsos, Founder and CEO of Rimsys. "Regulatory leaders don't have clear benchmarks to measure the performance of their teams. They're looking at digital transformation initiatives to improve the efficiency and effectiveness of their teams and want to understand what's possible, what really good execution looks like."
Key findings include:
Regulatory teams are lightly staffed compared to their workload.
A quarter of large medtech companies have 15 or fewer regulatory employees. These small teams complete over 100 renewals or license updates each year. Only 13% of companies make resourcing decisions based on anticipated workload, leaving any gaps to be filled with external consultants. Today, 90% of companies rely on consultants to complete regulatory projects.
Process failures are common.
Regulatory leaders self-assess the performance of their teams highly. A majority believe they outperform other regulatory affairs teams in similar companies in both project planning and execution. Yet over 60% reported a major non-compliance issue in that past year, and 24% had to withdraw products from a country or region due to non-compliance.
More on The PennZone
- Navigating a Changing Market: How AIX Group Is Responding to a Challenging Year
- 450 Million Revenue Run Rate, Global Telecom Reach and a New Digital Growth Opportunity Take Center Stage: IQSTEL, Inc. (N A S D A Q: IQST)
- Wave Helicopters Takes FLIBS 2026 to New Heights
- Canada's First Data Lakehouse Goes Global in Banking: Nabil Bank Becomes Nepal's First Bank to Implement a True Agentic Lakehouse Platform, DataNature
- Latin GRAMMY-Winning Cuban-American Conductor Dr Yalil Guerra to Lead Pepperdine's Oklahoma!
Digital transformation makes a measurable impact on productivity.
Companies are investing in process improvement, both by increasing staffing and growing technology budgets. They are moving away from generic productivity tools to more specialized solutions designed for regulatory processes. Companies that have implemented regulatory information management and regulatory intelligence systems report very high productivity gains and they complete regulatory projects more quickly.
Rimsys and PA Consulting, a global innovation and transformation consultancy, in conjunction with the Regulatory Affairs Professionals Society, will be presenting and discussing the survey findings in an interactive webinar on February 23, 2023. To attend, register here: https://bit.ly/performance-study-webinar.
"A major trend we are tracking this year is focused on Medtech's engagement with regulatory bodies against a backdrop of new requirements for advanced technologies such as AI, and evolving legislation such as the MDR and IVDR transition in Europe. This has forced organizations to re-evaluate old processes and adopt new tools," said Marck Aghnatios, MedTech Expert at PA Consulting. "The impact of this change will be largely absorbed by the regulatory affairs function – which is accurately reflected Rimsys' study findings. The industry imperative for medtech leaders will be to digitize their business functions – starting with regulatory."
Methodology
More on The PennZone
- Highsfield Showcases Earth Zoom Generator for Cinematic AI Videos
- Patton AI Launches Patton Hive 4.5: Wartime Breakthroughs for Drones and Robots When GPS Goes Dark
- Wisdom trumps wrinkles: 66% of Aussie women wouldn't turn back the clock
- Attorney Jason M. Sullivan Quoted in The Telegraph on Trump's $10 Billion BBC Lawsuit
- Sherri Horsey Darden: A Visionary Woman Building a Legacy of Inspiration, Community, and Excellence
Rimsys worked with a third-party market research firm to field and administer the survey in July 2022. Survey respondents included 200 regulatory professionals at medtech (medical device, in vitro diagnostic, and software as a medical device) companies headquartered in the United States, Canada, and the European Union. Companies were evenly sampled across all sizes, from $10 million to more than $1 billion in revenue.
To download the full Regulatory Performance report, please visit: https://www.rimsys.io/regulatory-performance-report.
About Rimsys
Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software digitizes and automates regulatory activities, helping medtech regulatory affairs teams to plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys centralizes all regulatory information, automates submission processes, and provides detailed visibility into product registrations, expirations, relevant standards, and global regulations. Traditional approaches to regulatory affairs can't keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys is designed around medtech regulations and workflows and supports a full breadth of regulatory activities including registrations, submissions, UDI, essential principles, standards management, and regulatory intelligence in a single, integrated platform. Leading global medtech companies including Johnson & Johnson, Siemens Healthineers, and Omron rely on Rimsys to better manage regulatory projects and resources, get new products to market more quickly, and reduce revenue risk of non-compliance, product recalls, and unexpected expirations. For more information, visit www.rimsys.io.
Contacts
Michael Peach
(855) 846-7269
michael.peach@rimsys.io
0 Comments
Latest on The PennZone
- Stand Strong Fencing of Hatfield Turns Every October Project Into a Cancer Donation
- New Children's Picture Book "Tippy Tay" Explores the Dangers of Peer Pressure and the Importance of
- Former Goddard Enterprises Managing Director Anthony Ali Joins STS Capital Partners as Managing Director and Partner
- Heritage at Manalapan Announces Limited-Time Mortgage Rate Buydown on Select Quick Move-In Homes
- Good Organics Now at Pop Up Grocer NYC With October 30 Sampling Event
- KeysCaribbean Announces Temporarily Reduced Rates At Village at Hawks Cay Villas
- Commercial Manufacturing Validation Completed as November 10 FDA Milestone Approaches; Critical FDA Milestone Close: NRx Pharmaceuticals NAS DAQ: NRXP
- Electives Launches "Electives for Everyone," Making Live Expert-Led Learning Available to Every Employee
- Tax Tops the List as Wealthy Brits Plan Their Exit, La Vida Survey Finds
- "The Tree of Cinema" Installation Brought Film History and Its Audiences Together at TIFF 2026
- Detroit Lawyer Steals $600,000 Settlement Meant to Protect Child
- The Great Junk Hunt Makes Its Highly Anticipated Stop in Philadelphia (Oaks)!
- Heritage at South Brunswick Announces Special Townhome Mortgage Rate Buydown
- Heritage at Hopewell Announces Limited-Time Mortgage Rate Buydown on Select Quick Move-In Townhomes
- Air Force Veteran Sean Douglas Delivers Powerful Suicide Prevention Presentations to Hundreds of Marines at Camp Pendleton
- Ashley Russo Receives Linny Lifetime Achievement Award
- How to Choose a Heating Repair Company in Philadelphia
- Renew Integrative Health Publishes Updated Peptide Therapy Guide to Help Patients Understand Their Options
- Lehigh County Drug and Alcohol Celebrates Grand Opening of Journeys
- Timbrana Addresses the Missing Follow-Through in Commercial Construction Projects