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.

Quality Management System
ISO Statutory
MDD (European Union)
ANVISA (brasil)
PMDA (Japan)
MDALL (Canada)
TGA (Australia)