Quality Manager as a Service (QMaaS)
Quality Manager defines, supervises, and operates your ISO 13485 and 21 CFR 820-compliant Quality Management System (QMS). The consultant will lead your QMS certification and support market approvals of your medical devices.
Quality Manager role
Find out more about activities a Quality Manager will deliver for your organization
1. Leading quality management
Defining quality management policies and objectives and aligning them with the company strategy. Ensuring the QMS definition corresponds to the organization’s processes and daily business activities.
2. Managing communication
Ensuring all stakeholders know their roles in the QMS and their impact on final medical devices’ quality. Communicating the importance of quality management and conformity with harmonized standards and regulations. Managing external communication.
3. Supporting product life cycle activities
Explaining, leading, and controlling all medical device product life (PLC) cycle activities. Supporting product team at all medical device (MD) product life cycle stages like product planning, risk management, requirements management, design and development, purchasing, production and service provision, clinical evaluation, vigilance, and post-market surveillance.
4. Coordinating product market approvals
Leading market approval activities like CE marking, 510(k), and others for the chosen national markets. Supervising the preparation of technical documentation. Taking part in the market approvals and conformity assessment procedures with the market regulators.
5. Supporting quality audits, certifications, and compliance
Continuous monitoring of the effectiveness of the QMS. Planning, coordinating, and presenting the outcomes of yearly audits. Tracking and supporting the QMS certification process and compliance with regulations and harmonized standards.
Role competency profile
Lower the costs of the QMS implementation by bringing already trained consultant
Quality Management (MD/MD IVD) practitioner
Our consultants have vast experience defining, certifying, and operating Quality Management Systems for MD and IVD MD manufacturers. They will lead the QMS definition project and support the execution of the relevant processes. They combine regulatory expertise with practical experience in implementing QMS, which adds value to the organization’s business.
Trained ISO 13485 external auditor
Part of the QMS definition is planning, coordinating, and reporting on internal and external audits. Our consultants are trained and certified ISO 13485 auditors. Thanks to that, the audits can promptly identify the possible areas for improvement and increase the safety of the produced medical devices. Additionally, all consultants are trained on the ISO 14971 risk management standard and practices.
ISO 13485/21 CFR 820 know-how set expert
Our consultants know ISO 13485/21 CFR 820 know-how set inside out. They have led the QMS definition projects based on that know-how set many times. It better adjusts the quality management know-how to your organization’s specificity and orchestrates quality management activities. The consultants always target building a QMS, which allows to place MD products on global markets.
Harmonized standards experience
To place a medical device on the market, the organization must work under the QMS and fulfill the requirements from the harmonized standards. Our consulting team brings expertise in managing standards like IEC 62304, IEC 82304, IEC 62366, ISO 27001, ISO 27701, ISO 27017, ISO 27018, or the US-relevant guidance documents.
Collaboration on ins2outs
Find out about collaboration with your Quality Manager on ins2outs
QMS Project execution
As part of our service, the consultant will prepare, present, and keep updating a plan to define and certify your QMS and product conformity assessment. You have complete insight into the QMS definition process at any moment.
The work from the plan is divided into weekly sprints. For each sprint, the team engaged in the project agrees on the tasks, deliverables, and actions to complete each week. Daily standups additionally improve communication.
Working with ins2outs
ins2outs handles all QMS and MD product life cycle (PLC) communication challenges. On the QMS level, the software automates reviewing the documents, notification of pending tasks, accepting and signing documents, training, and other activities. On the PLC level, ins2outs manage and release product life cycle documentation for reach medical device release.
The consultant will take part in the certification audits of your QMS in person. All your QMS and PLC documentation is stored and available on ins2outs, with all awareness and training records managed by the software.
Placing MD/IVD MD on the market
The quality manager will support the product team in placing MD/IVD MD products in the selected national markets. The completed technical documentation along the full product life cycle is kept on ins2outs. Technical documentation is managed in ins2outs software as well. At the moment of the product release, the complete version-specific documentation is automatically exported into a PDF zip repository and kept by the organization for at least ten years as required by e.g., MDR.
Benefits for your organization
Explore the benefits of engaging trained, experienced, and ins2outs-fluent consultant
Shorten by up to 75% your QMS implementation time
A management system implementation can be a quick and effective process. Combine ins2outs software, ready-to-use know-how sets, and our consultants to define and certify any management system in weeks, not years.
Instant access to the experienced consultants
Save time, effort, and money required to find and recruit an experienced consultant on the hot medical devices market. Bring expertise in the QMS definition and operations from day one.
Minimize the QMS project risk
Bringing ins2outs, the know-how set and our consultant triad can bring the project execution risk to nearly zero. You get your QMS faster, more efficiently, and earlier to start generating revenue from your medical devices on the market.
Shorten medical device market approval
It takes excellent coordination of intended purpose definition, product management activities, and managing notified bodies or market regulators to place a medical device on the market promptly. Shorten your path to market with experts.
Mitigate the potential liabilities costs
You increase product quality by building a robust and effective quality management system. Having your QMS monitored and MD products under surveillance allows you to react faster to any adverse events. You can reduce potential liabilities by setting an effective QMS as an MD manufacturer.
- Experienced Quality Manager
- Delivered via ins2outs
- Monthly net fee
- For organizations with up to 50 users
ISO 13485 / 21 CFR 820 Know-how set
- Defines ISO 13485 / 21 CFR 820-compliant QMS
- Requires ins2outs account
- One-time net fee
- For organizations of any size
- Requires one active user account
- Standard features package
- Full view and edit rights