Medical device industry is highly regulated. Various documents are required to demonstrate regulatory compliance. Standard operating procedures (SOPs) are one such essential document required for medical device approval and market launch. SOPs outline the framework for operational efficiency and regulatory compliance. Preparing an SOP can be cumbersome. However, an effectively written SOP can go a long way in hassle-free regulatory compliance and smooth market launch. Various SOPs are required for a medical device company. Preparing all of them simultaneously while launching a medical device company can be overwhelming. Hence, we have highlighted some crucial SOPs for medical device startup that should be prioritized early on.

What is a SOP?

SOP stands for standard operating procedure. It provides written instructions for completing specific tasks. SOPs are a critical document for medical device companies and vital for medical device development. They must be written with enough operational details so that anyone can follow the procedures to complete the task. Medical device companies use SOPs to ensure consistency in manufacturing processes, finished products, and people. Moreover, these documents provide guidelines for regulatory compliance and quality control activities. Furthermore, they improve the operational efficiency by ensuring everyone involved in the medical device production is on the same page. SOPs provide sufficient operational information that will enable anyone with relevant experience to replicate a procedure or a process.

Furthermore, SOPs serve as training documents for new employees or performance checklists for existing employees. Moreover, regulatory bodies want a well-structured SOP outlining stringent protocols for medical device development. Additionally, these SOPs form a basis for investigating root causes of quality issues associated with the medical device.

Need for SOPs for medical device startup

The medical device industry is stringently regulated with strict guidelines for medical device development and quality control. Ensuring compliance with these guidelines is of paramount importance. Hence, SOPs are vital for documenting all the process involved in medical device development, manufacturing, and quality control. SOPs for medical device startup is vital for documenting:

• Medical device development process
• Manufacturing processes
• Quality control
• Clinical evaluation
• Design controls
• Supplier management
• Defects or other problems
• Clinical investigations
• Post-market surveillance
• Biocompatibility

The SOPs for medical device startup should focus on properly documenting how each of the activities will be performed. Furthermore, SOPs should focus on quality assurance and regulatory compliance requirements. Additionally, it should outline a process for validating results and calibrating equipment.

How to write effective SOPs for medical device startup?

While preparing SOPs for medical device startup, it is vital to keep in mind the purpose of preparing the documents. Medical device SOPs are written for different purposes and have varying roles in the medical device industry. They can be prepared as a checklist for ensuring regulatory compliance. On the other hand, they can be prepared for achieving operational excellence. Hence, prior to preparing SOPs for medical device startup, it is important to understand the purpose of the SOP and for whom it is being written.

Unambiguous, clear, concise, and directive language should be used while writing SOPs for medical device startup. Moreover, it is important to be objective while writing medical device SOPs. Furthermore, the SOPs should be written from the user’s point of view who may not be subject matter experts. SOPs should be well-structured written in a clear step-by-step format for easy reading. Additionally, they should be precise providing exact measurements. Notably, the medical device SOPs should have consistency in format as well as should use minimal technical language to be reader friendly. It is best to prepare separate documents for different roles and responsibilities. Furthermore, it is vital to maintain version control records, to accurately document history of changes in the SOP. Using a SOP template, will help ensure all key information is included in the documents.

7 SOPs for medical device startup that should be prioritised

For launching and operating a medical device company, you need to prepare various SOPs. However, preparing all the SOPs at once can be overwhelming and cumbersome. Hence, we have listed some crucial medical device SOPs you should prioritize while launching your medical device startup.

1. Design and development SOPs for medical device startup

The design and development SOP provides guidelines for each phase of the medical device development. It covers everything from design inputs and outputs to verification and validation. This SOP plays a crucial role in ensuring regulatory compliance and meeting market requirements. The design and development SOP usually includes:

• Medical device design controls and documentation
• Review and approval of the medical device design
• Risk management during the design phase

Prioritizing the design and development SOP will help you avoid costly redesigns or delays in the future. Moreover, this SOP will ensure the medical device is regulatory compliant and prepared for regulatory scrutiny.

2. Device master file SOP

This SOP contains all the documentation related to the medical device’s design, manufacturing, and testing. The SOP is required to have the medical device’s lifecycle properly documented. It usually includes:

• Device specifications and drawings
• Manufacturing and medical device assembly instructions
• Inspection and test protocols

A well-prepared device master file SOP is vital for regulatory approval and audits. It provides a comprehensive overview of the product’s journey from design to market.

3. Supplier approval and management SOP

The raw materials used to manufacture the device has a vital role in determining the quality of your medical device. The SOP provides guidelines to carefully vet, approve, and continuously monitor the raw material suppliers. It includes:

• Raw material supplier qualification criteria
• Supplier audit protocol
• Raw material supplier performance evaluations
• Ongoing supplier monitoring

Prioritizing the supplier approval SOP will reduce the risk of receiving substandard raw materials that will negatively impact the device’s quality and regulatory compliance.

4. Process validation SOP

Process validation is required to ensure the medical device manufacturing process is capable of consistently manufacturing devices that meet regulatory and safety benchmarks. The process validation SOP is required to properly document the manufacturing process. It should include:

• Medical device process validation protocols
• Acceptance criteria and validation methods
• Ongoing process monitoring and revalidation protocols

Prioritizing the process validation SOPs will reduce the risk of manufacturing non-conforming devices.

5. Risk management SOP

A robust risk management procedure is vital for identifying, evaluating, and mitigating risks throughout the device’s lifecycle. The risk management SOP is required to proactively address the potential hazards associated with the medical device. It includes:

• Hazard identification and risk analysis protocol
• Risk mitigation strategies
• Ongoing and continuous risk assessment procedures

This SOP has a vital role in protecting end-users and the company from the consequences of the hazards associated with the device.

6. Document control SOP

This SOP focusses on how the documents will be created, reviewed, revised, approved, and archived. The SOP includes

• Procedures for document creation and review
• Version control and tracking of documents
• Access control and archiving of documents

Prioritizing document control SOPs for medical device startup ensures that all critical documents are traceable, up-to-date, and ready for regulatory inspection at all times.

7. Employee training SOP

Employee training SOP is required to ensure the employees receive proper training on regulatory requirements as well as manufacturing processes and procedures. The SOP includes:

• Initial and continuous training requirements
• Documentation of all employee training records

This SOP is vital to have a well-informed and trained workforce who can consistently maintain regulatory compliance.

Prioritising these seven aforementioned SOPs for medical device startup will provide a solid foundation needed to establish a medical device company. They will help ensure consistent product quality and regulatory compliance. Need help establishing a medical device company in India? We at Pharmadocx Consultants will be more than happy to help you. Our service covers CDSCO medical device license application, plant layout designing to SOP and detailed project report creation. Drop an email at [email protected] or call/Whatsapp on 9996859227 to launch your medical device business in a hassle-free manner.