In Vitro Diagnostics Regulation (IVDR) Changes
Listen to the entire episode where we go over all of the important things happening in the »ÆÈ˵¼º½ industry here.
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Device Classification Changes
- List-based Classification to a Rule-BasedÌý
- Class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body (NB) involvement.
- MDGC 202- 16 Guidance on Classification for in vitro diagnostic »ÆÈ˵¼º½s under Regulation (EU) .
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Lifecycle Approach
- Establishment and Demonstration of effective Quality Management Systems (QMS).
- More stringent requirements for clinical evidence that demonstrates conformity.
- Post-Market Performance monitoring and reporting requirements.
- Introduction of Unique Device Identifiers (UDIs) for improved traceability.
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Supply Chain Oversight
- Regulations covering the entire supply chain.
- Economic Operators
- Importers
- Distributors
- Authorized Representatives
- Economic Operators
- Notified Bodies have discretionary authority to audit suppliers and subcontractors
About RCA’s »ÆÈ˵¼º½ Consulting ServicesÌý
The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance »ÆÈ˵¼º½ can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.
Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance »ÆÈ˵¼º½ works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.
Cybersecurity
For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance »ÆÈ˵¼º½ medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.
At Regulatory Compliance »ÆÈ˵¼º½, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance »ÆÈ˵¼º½ medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.
- SaMD Consulting
- Threat Modeling
- Proof of Concept
- Quality Assurance Services
- TIR 57 & TIR 97
- ISO 62304
- ISO 27001
Regulatory Affairs
Regulatory affairs is Regulatory Compliance »ÆÈ˵¼º½Â® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts 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-market.
As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance »ÆÈ˵¼º½Â® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance »ÆÈ˵¼º½Â® medical device consulting company has expertise in both the approval process and post-approval support.Ìý
- New Product Approval
- Post-Approval Support
- Outsourced Staffing
- EU MDR
- Combination Products
Compliance Assurance
Increasingly, 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, Regulatory Compliance »ÆÈ˵¼º½Â® can help.
Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance »ÆÈ˵¼º½Â® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.
- Gap Assessments
- Internal Audits
- Employee Training
- Notified Body Response
- Data Integrity
Quality Assurance
Regulatory Compliance »ÆÈ˵¼º½Â® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance »ÆÈ˵¼º½Â®Ìýmedical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance »ÆÈ˵¼º½Â®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.
With more than 20 years experience working with medical device consulting companies, Regulatory Compliance »ÆÈ˵¼º½Â®Ìýtrusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.
- ISO13485Ìý
- 21 CFR 210
- 21 CFR 211
- Outsourced Staffing
- MDSAP
- Facility Validation
- Equipment Validation
- Quality Metrics
Remediation Services
Regulatory Compliance »ÆÈ˵¼º½Â® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance »ÆÈ˵¼º½Â® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
- Regulatory Action
- Regulatory Compliance
- Regulatory Enforcement
- Warning Letter
- 483 Observation
- Oversight Services
Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance »ÆÈ˵¼º½Â®Ìý a competitive differentiator in the remediation space.
- Quality System
- Technical File
- Design History File
- Data Integrity
- cGMP
Strategic Consulting
Whether it’s a strategy, a technical plan, or project, Regulatory Compliance »ÆÈ˵¼º½Â® medical device consultancy can help ensure a successful project. Regulatory Compliance »ÆÈ˵¼º½Â® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.
Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.
- Manufacturing Optimization
- Product Lifecycle Management
- Mergers & Acquisitions (M&A)
- Due Diligence
- Device Vigilance
- Risk Management Plan
- Product Complaints
- Medical Information
About Regulatory Compliance »ÆÈ˵¼º½
Regulatory Compliance »ÆÈ˵¼º½Â®Ìý(RCA) provides medical device consulting to the following industries for resolution of life science challenges:
- Life Sciences
- Pharmaceutical
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of , , and globally-regulated companies.
As your partners, Regulatory Compliance »ÆÈ˵¼º½ can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – ,ÌýÌýandÌý, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
To begin the Regulatory Compliance »ÆÈ˵¼º½Â® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.Ìý