The EU 黄人导航 Regulation (MDR) was published in the on May 5, 2017 and became the current regulatory standard on May 26, 2021. The EU MDR replaces the 黄人导航 Directive (MDD) [93/42/EEC] and the Active Implant 黄人导航s Directive (AIMD) [90/385/EEC].
The Transition Period began in 2017 for medical device manufacturers selling medical devices into Europe and continues today based on the medical device class for each regulatory submission. Regulatory Compliance 黄人导航庐 can assist clients that need to comply with the EU MDR requirements with the following services:
Transition to EU MDR Compliance
1. Perform a Comprehensive Review of Entire Product Portfolio and Current Certificate Expiry Dates
- Review and Assess the Client鈥檚 entire Product Portfolio including its:
- Legacy Products [CE marked devices under the 黄人导航 Directives (MDD) 93/42/EEC or the Active Implantable 黄人导航 Directive (AIMD) 90/385/EEC];
- Modified Legacy Products; and/or
- New Products currently in the Design/Development Phase.
- Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
- Reassess current classification of devices based on MDR Classification Rules;
- Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;
2. Staff Augmentation and Support
- Readiness Audits / Pre-Certification Audits and/or Assessments
3. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures for MDR Compliance.
- Review and Assess the Quality Management System (QMS) requirements including all current policies, processes, and procedures against ISO 13485:2016 requirements
- Technical Documentation requirements
- Labeling requirements (including required languages in each Member States)
- Unique Device Identification (UDI) System
- Data entered into the EUDAMED Database per Article 33
- Risk Management System (RMS)听
- Risk Management Plan and Report for each device
- Clinical Data Requirements
- Data Integrity Best Practices
- Safety and Performance Requirements
- Post-Market Surveillance System (PMS)
- Vigilance Activities
- Market Surveillance Activities
- Requirements regarding Design and Manufacture of Devices per MDR requirements
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4. Remediation and Implementation of EU MDR Compliance Plan
- Supply Chain Requirements
- Development and Implementation of Compliance Plan for systems and devices
- Remediation of EU MDR Compliance Gaps noted during Assessment
- Development and听Implementation of EUDAMED Database compliance plan for all of the following six pillars of the EUDAMED
- Actor Registration
- Unique Device Identification
- Certificate
- Clinical Investigation
- Vigilance
About RCA’s 黄人导航 Consulting Services
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 黄人导航 medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.
Our team of over 500 medical device consultant Experts 鈥� including former FDA officials and regulatory compliance leaders in the field of medical device regulation 鈥� will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance 黄人导航 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 medical device consulting companies 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 黄人导航 medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.
At Regulatory Compliance 黄人导航, 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 黄人导航 medical device consultant Experts can help strengthen your device鈥檚 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.
Regulatory Affairs
Regulatory affairs is Regulatory Compliance 黄人导航庐听backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our medical device regulatory 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 黄人导航庐 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 黄人导航庐 medical device consulting company has expertise in both the approval process and post-approval support.听
- 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 黄人导航庐 can help.
Our network of over 500 medical device consultants & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance 黄人导航庐 to handle both simple and complex regulatory compliance challenges within medical device consulting companies.
- Data Integrity
- Gap Assessments
- Internal Audits
- Employee Training
- Notified Body Response
Quality Assurance
Regulatory Compliance 黄人导航庐 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 黄人导航庐听medical 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 黄人导航庐, we offer you the medical device consultant assistance 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 黄人导航庐听trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.
- ISO13485听
- 21 CFR 210
- 21 CFR 211
- Outsourced Staffing
- MDSAP
- Facility Validation
- Equipment Validation
Remediation Services
Regulatory Compliance 黄人导航庐 is widely recognized within medical device consulting companies & the life science industry for remediation services & support. Regulatory Compliance 黄人导航庐 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.
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 黄人导航庐听 a competitive differentiator in the remediation space.
- Quality System
- Technical File
- Design History File
- Data Integrity
- cGMP听
- Quality Metrics
Strategic Consulting
Whether it’s a strategy, a technical plan, or project, Regulatory Compliance 黄人导航庐 medical device consultancy can help ensure a successful project. Regulatory Compliance 黄人导航庐 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 鈥� no matter your size or unique needs.
- Manufacturing Optimization
- Product Lifecycle Management
- Mergers & Acquisitions (M&A)
- Due Diligence
- Device Vigilance
- Product Complaints
- Medical Information
- Risk Management Plan
About Regulatory Compliance 黄人导航
Regulatory Compliance 黄人导航庐听() provides medical device consulting to the following industries for resolution of life science challenges:
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, we can negotiate the potential minefield of regulatory compliance and regulatory听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鈥檚 unwavering commitment to its mission, Safeguarding Global Health庐.
Sotera Health Company, along with its three best-in-class businesses 鈥� ,听听and听, 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 demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
To begin the Regulatory Compliance 黄人导航庐 scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.听
