Medical Device Quality Management Systems

Superior Medical Devices Quality Management Services from MDR Consultants

Every medical device manufacturer must develop and manage proper quality control guidelines for their products. This ensures that the company abides by set quality guidelines and the products are safe for clinical use. Even though quality control and assurance for medical devices are essential for the success of your business, it is not your core business. This is why medical device manufacturers should consider hiring MDSAP consulting firms.

 

At MDR Consultants, we help startups and established medical device companies with all their quality control issues. By outsourcing your medical device quality management functions, you can rest assured that we will deliver up-to-date and technically sound QMS solutions.

 

Seasoned Experts

 

At MDR Consultants, we have an experienced team of quality and regulatory professionals who are also engineers with decades of hands on experience not only in working in industry but also in working as notified body auditors for leading certification bodies. When you work with us, you are assured of getting the best services from a quality and regulatory assurance team that has years of industry experience. This simply means that you will get advice and expert guidance from the best experts of the industry. 

 

We Handle Everything For You

 

Regardless of your medical device quality control issue, MDR Consultants is here to help. Our team of experts will help you whether you are preparing for you product’s FDA approval or clearance, getting your ISO 13485:2016 certification, your EU MDR certification, your MDSAP (Medical Device Single Audit Program) certification or just want to tighten your in-house quality strategies and related processes. When you outsource your quality and regulatory functions to our team, you will get a simple and risk-based solution from a dedicated quality team. 

 

A Range of Quality Management System Services

 

At MDR consultants, we pride ourselves in offering our clients passionate services that result in a superior quality finished product. When you choose an expert of our MDR Consultants firm, you will get guidance, perks, and insights that are specific to your medical device product and specific to your company’s quality management system applicable processes. Some of our services include:

  • The identification, documentation, review, update, maintenance, control, and/or implementation of the right processes of your organization’s quality management system in accordance with the products you offer, the services you offer, and the processes required to meet all applicable statutory and regulatory requirements.
  • On-call access to a seasoned quality team without the need of paying an in-house quality department.
  • Reliable support for the understanding and preparedness to regulatory and statutory audits to include FDA inspections, Notified Body Certification Audits, Competent Authority Audits, and clients or business partners audits.
  • The capacity to align the best quality system tasks to great team members who have the skill and knowledge to make things more effective and efficient. 

 

When you work with us, you can rest assured that we not only know everything about the relevant regulatory and statutory requirements a medical device manufacturer must meet, but we also understand how to design and implement processes that are lean, effective, and support the implementation of an organization’s quality management systems goals, policies, and overall business objectives. Our MDSAP consultant services will help your employees focus on more important tasks, avoid the struggles associated with quality management systems requirements, and help you save money in the long run. Outsourcing your medical device quality control needs will make your work easier. Contact us today to enjoy professional services from the experts.

FDA Quality and Risk Management Systems

Medical Device Risk Management Consulting Services

Medical device risk management is an integral part of every phase of your quality management system and it shall be included in all processes. However, special emphasis on implementation of related requirements should be placed on processes that control the design, development, manufacturing, complaint, reporting, vendor controls, training, and management of post-production data. Whether you want to design a new medical device or improve an existing product, your risk management processes and their implementation should be rigorous to ensure the product meets intended purpose and use and if applicable, to obtain FDA or CE Mark approval. 

 

At MDR Consultants, our risk analysis medical device consulting services involve the identification, understanding, documentation, implementation, control, and .maintenance of processes and outputs that are complaint and conformant to all applicable national and international Risk Management requirements to include FDA regulatory requirements, ISO 13485:2016 and ISO 14971:2019 statutory requirements, MDSAP statutory and regulatory requirements, and EU MDR regulatory requirements. The ultimate objective of any medical device manufacturer is to ensure that their products and services meet their intended use and to ensure their products and services perform as expected while maintaining a preapproved risk-benefit ratio. Through our services, we can help medical device manufacturers identify and classify design, production, and use related risks to ensure that all required mitigation activities are implemented and to ensure they are effective. 

 

We Handle the Complexities of Risk Management

 

For most medical device manufacturers, the implementation of risk management processes may appear simple. However, the reality is that the implementation of risk management processes is governed by many statutory and regulatory provisions that requires careful design and implementation of these processes not only to ensure that the medical device meets all pre-determined requirements but also to ensure compliance and conformance to applicable requirements. At MDR Consultants, we have years of hands-on experience in the design, documentation, implementation, control, and maintenance of processes and outputs that meet all applicable requirements to include but not limited to FDA quality systems regulations, to ISO 13485:2016 and ISO 14971:2091 standards, to EU MDR Risk Management Processes Regulatory Requirements, to MDSAP statutory and regulatory requirements.

 

Control Risks to Improve Overall Medical Device Performance

 

At MDR Consultants, we employ a collaborative and comprehensive approach that helps risk management processes to be implemented as an important and inherent part of the product life cycles, quality management systems, and supply chain operations designed to deliver ultimate patient safety. 

 

With our years of experience in compliance and conformance of  quality management systems, we can provide insight into the appropriate identification, management, and mitigation of all the risks related to medical devices produced in the medical devices manufacturing industry. We strive to recognize and mitigate risks early enough and not just as an afterthought after production or product release. Our team of FDA risk assessment medical devices experts will ensure that risk controls are implemented throughout the entire lifecycle of the medical device to ensure that devices. meet pre-established requirements and their intended use. 

 

Professional Risk Management Services

 

Quality monitoring, compliance, and risk management are interconnected in the medical devices industry. When you partner with MDR Consultants for your risk assessment of medical devices, you can be assured of the following:

  • You will meet your risk management regulatory and statutory requirements
  • Be conversant with any potential hazards
  • Make data-driven decisions that will enhance risk mitigation and avoidance
  • Meet your business objectives
  • Prepare for growth

 

To mitigate risks, you need to be aware of potential threats and formulate the right strategy. With years of experience in the industry, we provide effective FDA medical device compliance and conformant solutions that will help you manage risks proactively within the medical device field. At MDR Consultants, our goal is to help every medical device manufacturer to become risk agile and adept.

Special Projects

  • QMA transition to the new EU MDR and/or MDSAP
  • Implementation of ISO 13485:2016
  • Implementation of ISO 14971:2019 or ISO 14971:2012 or ISO 14971:2007
  • Gap Analysis
  • Design and Development of products from idea to market
  • Risk Management
  • Quality Management System Procedure(s) Generation
  • Pre-market Submissions and Licensing (PMA, 510k, Registration, etc.)
  • Technical File Generation and Maintenance
  • Design and Development of products from idea to market
  • Clinical Evaluations
  • Post Market Surveillance
  • Vigilance
  • Remediation Projects or Initiatives
  • 483 Response

Training

Customized classes against applicable criteria.

Internal and Vendor Audits

Against the following criteria:

  • EU MDR
  • EU MDD
  • MDSAP including all participating members (Brazil, Canada, USA, Japan, and Australia), official observers (The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme, European Union) and affiliate members (Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) and Republic of Korea’s Ministry of Food and Drug Safety
  • ISO 9001:2015
  • ISO 13485:2016
  • ISO 14971:2019
  • Quality Agreements
  • Contract Agreements
  • Vendor Agreements
  • Quality Management System Process

Quality Management System

Implementation, Documentation, Monitoring, Support, and Management against all applicable requirements under the Medical Device Industry Umbrella.