February 09, 2021
What is a medical device consultant, why a medical device consulting firm selection is important, and how it can help you?
Let us find out in this blog:
What is a medical device consultant?
A medical device consultant is a medical device industry expert with years of hands-on experience in all aspects of the quality management system (QMS), with in-depth knowledge of applicable standards, regulations, and related guidance documents and their proper implementation. Depending on their professional and educational background, he or she is often an expert on the technical aspect, technology, and science behind several medical devices. This person or firm can help your organization ensure compliance or conformance to applicable requirements so that your organization can produce products that always meet requirements and that they perform as intended.
A consultant is a person or a member of a company like MDR Consultants Inc., a Medical Device Consulting Firm, that can help medical device companies in the following ways:
- As related to the Quality Management System (QMS):
- A consultant can help a medical device company with the creation, documentation, implementation, improvement, monitoring, maintenance, compliance, conformance, or review of their existing QMS against applicable requirements.
- If the company identified the need to update their QMS against a new requirement, a consultant with expertise on this requirement can help the organization transition its QMS to meet it either by performing a gap assessment and presenting the results to the organization so it can take actions, by remediating it the appropriate processes and outputs, by providing specialized training to process owners so they can update the impacted processes or by performing a combination of these activities.
- As related to internal or external Audits:
- A consultant can help a member of industry understand the gaps in their QMS and related outputs against internal requirements, standards, regulations, or guidance documents by performing their internal audits.
- A consultant can perform an audit against an established quality agreement, a contract agreement, standards, regulations, or a combination of both on any member of the organization’s supply chain to ensure they are in compliance and/or conformance with applicable requirements.
- A consultant can perform a mock audit against any relevant standard or regulation or against the organization’s internal requirements with the objective of assessing the level of compliance and/or conformance of the QMS and to prepare the organization and staff for an audit from a notified body, a government, or a competent authority.
- As related to Products:
- A consultant can help an organization to launch a product into market by supporting, reviewing, documenting, implementing, or assessing any aspect of the design and development process or the manufacturing process.
- A consultant can document or create the technical documentation required to obtain approval for market release from a government, a notified body, or competent authority as applicable and as required.
- A consultant can evaluate, edit, or assess the marketing documentation and labelling of products to ensure compliance and conformance to applicable requirements.
- A consultant can create, document, review, or assess the organization’s risk management processes to ensure that the risks associated with the use of the product are adequately evaluated, mitigated, and controlled in accordance with applicable requirements.
- A consultant can design, document, review, or assess effectives of implementation of the clinical evaluation and the organization’s post market surveillance system.
- As related to the Supply Chain:
- A consultant can help with the review, qualification, evaluation, management re-qualification, or monitoring of the organization’s supply chain.
- A consultant can document, implement, or review the quality agreements or contract agreements to ensure first, that they support the compliance and conformance against applicable requirements of the parties involved and second, that they provide objective evidence of adequate control of the processes performed by the supply chain.
- As applicable to resources:
- A consultant can provide additional human resources for the organization to ensure that required tasks under the QMS are performed on time and in compliance and conformance with applicable requirements.
- A consultant can provide training to members of industry against applicable standards, regulations, and/or guidance document to ensure that the organization’s personnel is competent to perform their work and to ensure that they understand the applicable requirements of their organization’s QMS.
- As applicable to other aspects:
A consultant can also take the role of a member of management to ensure that the organization meets competency requirements.
Because of how critical the consultancy services that a Medical Device Consulting Firm may provide to your organization, it is imperative that you ensure that the competence, educational background, knowledge, and expertise of the members of the firm is in line not only with the products that you produce or want to produce but also that they are experts and familiar with the documentation, implementation, and assessment of applicable standards, regulations, and/or guidance documents you claim or seek compliance and/or conformance against through your quality management system and that this expertise is verifiable.
The selection of a Medical Device Consulting Firm is important because, the services they provide to your organization, may impact your products’ speed to market release, the speed of your approval or certification process, the human and monetary resources you will need, but most importantly the level of compliance and conformance of the processes or product their services impact.
At our Firm, MDR Consultants Inc. our team members are engineering with decades of hands-on experience in every aspect of the medical device industry quality management system, design and development of products from idea to market, manufacturing, risk management, testing, verification, validation, labelling, packaging, vendor control and much more. This expertise comes from working in industry as well as from working as lead auditors and trainers of industry for leading notified bodies managing all schemes under the medical device industry to include ISO 9001, ISO 13485, ISO 14971, MDSAP (all applicable jurisdictions), MDD and EU MDR and related guidance documents. We also offer industry specific courses designed to ensure awareness of requirements and implementation.