Bio-Medical Engineering/ Pharma Industry
Tekhawks will operate as a standard human resource recruiting firm to help the medical device and pharma industries in hiring great employees, allowing them to stay focused on their core business. We will ensure that we work hard to provide the required consulting services and staffing solutions needed by our clients to accomplish their business goals and objectives. Our services will cover areas in the medical device and pharma industry such as:
Every Quality Audit program must include:
• Audit planning to include when and where audits will be completed.
• Qualified auditors to complete the audits.
• Documentation of audit findings
• Action plans to address audit findings
Here at Tekhawks, we provide you least burdensome approach to complying with international standards such as ISO 13485, FDA regulations 21CFR 820, and other global QMS requirements.
Enabling manufacturers or organizations to build a customer-centric quality product is the key to our success at Tekhawks.
Quality Management system:
The quality Management system is the heart of any medical device lifecycle. An organization based on a comprehensive quality management system can be considered trustworthy, and competent to produce quality medical devices.
The Quality system is a comprehensive system to ensure the products are safe, useful, and meet the regulatory requirements. It is a structured system of procedures and processes covering all aspects but not limited to design manufacturing, supply, risk management, management responsibility, customer-related processes and corrective actions, and preventive action measures. The purpose of QMS is to have an optimal end product and more importantly, to minimize the risk for end-users.
To effectively ensure that a quality system is compliant with quality and business objectives, an organization must have quality audit programs in place.
Our team is focused to ensure all the quality management system aspects are taken care of with the utmost attention.
Risk Management:
The most successful medical devices in the market are the ones that are the safest. Bringing down the risks associated with any medical device is essential to gaining the confidence of the consumers. Understanding and implementing ISO 14971 paves the path for launching the safest device in the market.
The Risk Management Process is carried out through the life cycle of the product, beginning at the product conception phase, continuing to be updated through all product development phases, through production, post-production, and ending at product obsolescence.
The Risk Management Process includes a problem resolution process. The Risk Management Process utilizes a medical device approach that results in one Risk Management File for each medical device. The Risk Management File includes all the Risk Management documents for the medical device. The documentation structure for a specific medical device RMF is documented in the respective master risk management plan.
Risk Management begins in the design phase of a product building a firm foundation. After having worked on the new product development project three things are required to make sure:
- Was the risk management implemented appropriately?
- Is the overall residual risk acceptable?
- Are methods in place for collection and review of production and postproduction info?
Our experienced risk management engineers provide customized solutions for given scenarios.
The application of ISO 14971 varies based on classes of devices. Tekhawks will assist in the risk management process for each stage such as concept, design, production, and post-production of the medical device lifecycle.
EU MDR, MDSAP, UKCA
The ultimate goal of developing any medical device is to help people. Introducing these medical devices in global markets require certifications from respective regulatory authorities. To get the certification of conformance you need to comply with the regional regulations, standards, or guidance.
Deriving strategies for submissions and certifications audits and making organizations ready for any challenges during submissions or audits are some of our expertise at Tekhawks.
New regulations have been established by the European Union for medical devices and in-vitro devices. They were published in May 2017 with 3-year (EU MDR) and 5-year for the In Vitro Diagnostic Regulation (EU IVDR) transition timelines.
The new Medical Device Regulation replaces the Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD). The new In Vitro Diagnostic Regulation replaces the In Vitro Diagnostic Directive (IVDD). Compliance is required within the transition timelines to continue selling CE-marked devices in the EU market and other global markets that rely on CE marking.
Every manufacturer is trying to get ahead to get compliance with the newly implemented EU MDR for their early advantage. Our team at Tekhawks helps manufacturers to get approval quickly. The team can offer guidance and assistance in creating the gap assessment between MDD and MDR, suggesting remedial actions and closing out the identified gaps.
The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure a single audit will provide efficient yet thorough coverage of regulatory requirements. These requirements include; Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016), the Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Japanese Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), the Quality System Regulation (21 CFR Part 820), and specific requirements of the medical device regulatory authorities participating in the MDSAP program.
The UKCA (UK Conformity Assessment) mark will be required to be placed on all in-vitro diagnostics, medical devices, and active implantable medical devices in England, Scotland, and Wales (GB) by 30th June 2023.
The existing directives that are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) will continue to exist in GB.
Technical Communications
Labeling and IFUs are the means how we convey information about a medical device to the end-users. This is the crucial element to convey any residual risks discovered during the risk management process. There are international guidelines and regulations such as ISO 20417:2021, ISO 15223-1, and EU MDR, which a manufacturer needs to comply with.
Label Types:
• Device label: Label appearing directly on the device. Sometimes referred to as “product label”
• Sterile / non-sterile package label: Label appearing on the immediate container (e.g., pouch or tray)
• Sales package label: Label appearing on the outside container or wrapper which is intended to be displayed, presented, or shown for sale (e.g., box)
• Software (CD/DVD) label: Label content appearing on a product CD/DVD
• Informational label: Label bearing information to support the distribution of the product; this label is not intended for compliance
• Convenience Kit label: Label appearing on the outside container or wrapper for a convenience kit
IFUs and Labels shall meet all applicable requirements, standards, and regulations as determined by Quality Management and Regulatory Affairs.
Information provided in terms of warning, precautions, indications, and contraindications is critical when the devices are being used by the lay persons. Artwork, device description, and manufacturer information are some of the pieces on the label that need to be drafted with a lot of care and attention.
Catering to the unique needs of a manufacturer at conveying the right information via labeling, our engineers will aid in meeting all these requirements.
Usability Engineering / Human factors
Usability engineering is about understanding who uses the medical device, the tasks of the users, the environment in which they will use it, and designing a great user interface.
The Usability Engineering process starts with use specification. Use specification is a document that includes all the information about the users, the document is considered as an extended form of the intended use, and getting information is crucial for the success of the product which becomes clear if you have look at the example below:
Imagine you are talking about a glucose measuring device if it is used in a home use environment by a young child, you will need to prepare a different device compared to a device that will be used by a professional caregiver in a hospital environment, even more, the same could be true if you are looking only at home use environment, imagine you’re comparing a device that will be used only by kids with one that is used only by elderly people, they will most probably be designed completely differently. To make sure that your device will be good and safe, you must take great care in identifying the right user profiles and writing down all the information that makes this user so special to make sure this does not include the characteristics of the person but also characteristics of the tasks and the use environment.
The root cause identified for large numbers of adverse events is determined to be user error. Users are prone to misuse or make an error while using the device as usability aspects are not considered during device development. A recent update in ISO 62366 forces manufacturers to take care of usability/human factor engineering in detail.
Tekhawks have a team with extensive experience in conducting usability studies, formative and summative evaluations, and suggesting risk control methods for different scenarios. It will help the manufacturer to cover the usability aspect of any medical device thoroughly.
Clinical Data Meddev 2.7.1.
As a manufacturer, you have identified your study, designed a powerful study plan, defined the inclusion and exclusion criteria and now you’ll need to decide on how you will collect the study data, your method of data collection can vary based on:
- The risk of your study,
- Type of study
- Complexity of your study
- One country or several countries
- Classification of the study, data points, type of measurements, and budget.
The development of a medical device is mainly based on the clinical data available for the device’s intended use. The availability of clinical data determines the risk profile of the medical device in the development stage.
Basics of clinical data management are critically important to determine if any clinical investigations/trials are required. Clinical data experts at Tekhawks guide manufacturers to utilize available clinical data in the most efficient way. In case of clinical data unavailability, these experts will provide manufacturers appropriate path to generate credible data.
Manufacturing Engineering
Manufacturing can be defined as the conversion of raw materials into useful articles using physical labor or the use of power machinery.
The manufacturing process is where the design shapes into the real world. Transferring design to the manufacturing floor takes much understanding of design, raw materials, processes, and their inter-relation. A systematic approach to establishing manufacturing processes, their validation, and establishing the right controls is essential to manufacturing the right product.
Manufacturing processes can be classified into the following:
- Primary shaping or forming processes
- Deforming processes
- Machining/removing processes
- Joining processes
- Surface finishing processes
- Material properties modification processes
Deriving protocols and flow charts are the expertise of our team at Tekhawks. The team completes all the due diligence and assists in filling out the gaps in the manufacturing process if any.
Verification and Validation
Verification and Validation assure the design and manufacturing specifications for a medical device are adequate. It also provides conformity evidence to the applicable guidance, standards, and regulations.
Design verification confirms by examination of objective evidence that design outputs fulfill specified design input requirements. Design verification activities include (but are not limited to) testing, inspection, and analysis and should include testing of normal and challenge conditions (e.g., worst case, boundary, failure, positive, and negative cases).
When you have designed the product, you should check that the design or product you came up with meets the regulatory requirements you defined at the beginning, this is a general principle in product development in the medical device industry. If we use design control terminology, we will call this design verification.
Design validation ensures that the product meets the user’s needs and can meet the requirements for the specified application, intended uses, and instructions for use by testing initial production units or their equivalents under actual or simulated-use conditions. Design validation activities include (but are not limited to) testing, pre-clinical and clinical studies, and usability studies. All validation activities shall consider the range of clinically relevant conditions for which the product is indicated for use (e.g., user profiles, use environments, programming settings, etc.) and shall include software validation and risk analysis, where appropriate.
Tekhawks can help in the planning and execution of design verification and design validation activities for products designed and developed by or for the manufacturers, our engineers can provide solutions for process validation which includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for separate operations.
Software as a Medical Device
The involvement of software and technology in medical devices is increasing day by day. As the software and the technology is evolving the reliance on these is expanding. To cope with the complications of software-integrated medical devices, one needs a specialized team that understands various aspects such as SDLC, cybersecurity, and data protection.
In terms of medical devices with software, the most common device that one is likely to encounter will be a device that is embedded with a microcontroller (containing software) performing a medical device function either diagnostic or therapeutic. However, an evolving field – what’s known as software as a medical device, where you have software that is not associated with any dedicated electronics hardware but would run on a traditional platform such as a PC, Server, Cloud Server, or a mobile device.
The main objective of any manufacturer is to develop software that is safe, reliable, and bug-free, to maintain software for the life of the product, including functional enhancements, and to manage software-related risks to patients, operators, and the environment.
Software engineers at Tekhawks are well equipped with their software knowledge along with medical device concepts. Our purpose is to provide guidance for software development activities and specify the requirements for software development.
Navigating through various situations related to software as a medical device becomes easier with Tekhawks.
